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To Evaluate if Green Tea Can be Effective in Reducing the Progression of Prostate Cancer in Men on Close Monitoring

NCT ID: NCT04597359

Last Updated: 2025-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-05

Study Completion Date

2032-12-31

Brief Summary

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This phase II trial studies how well green tea catechins work in preventing progression of prostate cancer from a low risk stage to higher risk stages in men who are on active surveillance. Green tea catechins may stabilize prostate cancer and lower the chance of prostate growing.

Detailed Description

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PRIMARY OBJECTIVE:

I. To compare the change in the percent (%) Ki-67 expression in a biopsy core positive for cancer from baseline to end-of-study (EOS) biopsy between men on active surveillance (AS) for prostate cancer (PCa), treated with green tea catechins (GTCs) or placebo for 6 months.

SECONDARY OBJECTIVES:

I. To assess apoptosis by caspase in tumor tissue from EOS biopsy by treatment. II. To assess % Ki-67: Apoptosis ratio from EOS biopsy by treatment. III. To evaluate the number of biopsy cores positive for cancer from EOS biopsy by treatment.

IV. To evaluate the percentage of any biopsy tissue core positive for cancer from EOS biopsy by treatment.

V. To evaluate % Ki-67 in EOS biopsy from the same quadrant matching the quadrant with the highest % Ki-67 at baseline treatment.

VI. To evaluate the Gleason sum from EOS biopsy by treatment. VII. To evaluate the change in serum prostate-specific antigen (PSA) from baseline to 3 months and to EOS by treatment.

VIII. To evaluate the safety of 6 month administration of GTC assessed by Common Toxicity Criteria (CTC) version 5.0, complete blood count (CBC), comprehensive metabolic panel (CMP) and liver function toxicities (LFTs) by treatment.

IX. To evaluate the change in geometric mean of % Ki-67 measures in all the cores positive for cancer from baseline to EOS biopsy by treatment.

EXPLORATORY OBJECTIVES:

I. To evaluate the change in catechin (epigallocatechin gallate \[EGCG\]) as indicated by change from EGCG measured in plasma from baseline and EOS by treatment.

II. To evaluate the adherence and acceptability to GTC based on the percentage compliance using agent logs (%) and pill counts monthly until EOS by treatment groups.

III. To evaluate the bioavailability of GTC as indicated by change from EGCG measured in plasma from baseline and EOS by treatment groups.

PATIENT REPORTED OUTCOMES OBJECTIVES:

I. To evaluate the change in lower urinary tract symptoms (LUTS) from baseline to 3 months and to EOS using the LUTS scale by treatment groups.

II. To evaluate the change in quality of life (QOL) scores from baseline to 3 months and to EOS using the Functional Assessment of Cancer Therapy (FACT)-Prostate by treatment groups.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive green tea catechins orally (PO) twice daily (BID) for up to 6 months in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive placebo PO BID for up to 6 months.

After completion of study, patients are followed up at approximately 7 days, at 6 months, and then up to 12 months.

Conditions

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Prostate Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm A (green tea catechins)

Patients receive green tea catechins PO BID for up to 6 months in the absence of disease progression or unacceptable toxicity.

Group Type EXPERIMENTAL

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Sinecatechins

Intervention Type DRUG

Given PO

Arm B (placebo)

Patients receive placebo PO BID for up to 6 months.

Group Type PLACEBO_COMPARATOR

Placebo Administration

Intervention Type DRUG

Given PO

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Placebo Administration

Given PO

Intervention Type DRUG

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Sinecatechins

Given PO

Intervention Type DRUG

Other Intervention Names

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Quality of Life Assessment Camellia sinensis Leaf Catechins Kunecatechins Polyphenon E Polyphenon E TM Veregen

Eligibility Criteria

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Inclusion Criteria

* Patient must have biopsy-proven (consisting of \>= 12 tissue cores) adenocarcinoma of the prostate with cancer present in at least one biopsy core in the most recent biopsy using initial transrectal ultrasound (TRUS) biopsy or TRUS biopsy followed by multiparametric magnetic resonance imaging (mpMRI) of the prostate and a confirmatory targeted biopsy
* Patient must be on active surveillance (very low, low and favorable intermediate risk as defined by the National Comprehensive Cancer Network \[NCCN\])
* Patient must be scheduled for a follow up prostate biopsy 6 months after the initiation of treatment on this study
* Patient must have a serum PSA \< 10 ng/mL or prostate specific antigen density (PSAD) \< 0.15 ng/mL/ g obtained within 30 days of registration
* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Patient must be willing to abstain from consumption of any supplements containing green tea catechins
* Patient must be willing to restrict tea consumption to less than three (3) servings of hot tea or three (3) servings of iced tea per week (serving size of 8 oz)
* Patient must be willing to discontinue current vitamin/mineral supplement use and use one provided by study
* Patient must be willing to take study agent or placebo at the dose specified with meals
* Patient must have the ability to understand and the willingness to sign a written informed consent document
* Absolute neutrophil count \>= 1,200/mm\^3 (\>= 1.2 k/uL) (obtained within 30 days prior to registration)
* Platelets \>= 75,000/mm\^3 (\>= 75 k/uL) (obtained within 30 days prior to registration)
* Total bilirubin =\< 1.2 mg/dL (or =\< 3.0 mg/dL for patients with Gilbert's syndrome) (obtained within 30 days prior to registration)
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 1.5 x upper limit of normal (ULN) (obtained within 30 days prior to registration)
* Serum creatinine =\< 1.5 x ULN (obtained within 30 days prior to registration)
* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
* Sexually active males must use an accepted and effective method of double barrier contraception (vasectomy must be combined with a physical barrier method) or abstain from sexual intercourse for the duration of their participation in the study
* Patients must have archived formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen available for Gleason score confirmation and % Ki-67 expression (5% or more) in tumor tissue for eligibility and stratification. Tumor tissue can be submitted any time during screening

* Tumor tissue specimen has been collected and is ready to ship to H. Lee Moffitt Cancer Center \& Research Institute

* H. Lee Moffitt Cancer Center \& Research Institute will perform Gleason score confirmation and % Ki-67 expression (5% or more) in tumor tissue and notify the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network (ECOG-ACRIN) Operations Office and submitting institution within 3-4 business days of receipt of the tumor tissue specimen
* Patient must meet all Step 0 eligibility criteria at the time of their registration to Step 1
* Patient must have Gleason score (3+3) or predominant Gleason pattern 3 (3+4), =\< 33% of biopsy cores, and =\< 50% involvement of any biopsy core
* Patient must have % Ki-67 expression of 5% or more in tumor tissue

Exclusion Criteria

* Patient must not have had prior treatment for prostate cancer, including focal therapy, with surgery, irradiation, local ablative (i.e., cryosurgery or high-intensity focused ultrasound), or androgen deprivation therapy
* Patient must not have a history of renal or hepatic disease, including history of hepatitis B and C
* Patient must not have prostate cancer with distant metastases
* Patient must not have undergone treatment of hormone therapy, immunotherapy, chemotherapy and/or radiation for any malignancies within the past 2 years. Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
* Patient must not receive any other investigational agents while on this study
* Patient must not have a history of allergic reactions attributed to tea or other compounds of similar chemical or biologic composition to green tea extracts
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

ECOG-ACRIN Cancer Research Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nagi B Kumar

Role: PRINCIPAL_INVESTIGATOR

ECOG-ACRIN Cancer Research Group

Locations

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Fairbanks Memorial Hospital

Fairbanks, Alaska, United States

Site Status RECRUITING

Cancer Center at Saint Joseph's

Phoenix, Arizona, United States

Site Status RECRUITING

Highlands Oncology Group - Fayetteville

Fayetteville, Arkansas, United States

Site Status ACTIVE_NOT_RECRUITING

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

Site Status RECRUITING

CHI Saint Vincent Cancer Center Hot Springs

Hot Springs, Arkansas, United States

Site Status SUSPENDED

CARTI Cancer Center

Little Rock, Arkansas, United States

Site Status RECRUITING

Highlands Oncology Group - Rogers

Rogers, Arkansas, United States

Site Status ACTIVE_NOT_RECRUITING

Highlands Oncology Group

Springdale, Arkansas, United States

Site Status ACTIVE_NOT_RECRUITING

Mission Hope Medical Oncology - Arroyo Grande

Arroyo Grande, California, United States

Site Status RECRUITING

Marshall Cancer Center

Cameron Park, California, United States

Site Status RECRUITING

Mercy Cancer Center - Carmichael

Carmichael, California, United States

Site Status RECRUITING

Mercy San Juan Medical Center

Carmichael, California, United States

Site Status RECRUITING

Epic Care-Dublin

Dublin, California, United States

Site Status ACTIVE_NOT_RECRUITING

Mercy Cancer Center - Elk Grove

Elk Grove, California, United States

Site Status RECRUITING

Bay Area Breast Surgeons Inc

Emeryville, California, United States

Site Status ACTIVE_NOT_RECRUITING

Epic Care Partners in Cancer Care

Emeryville, California, United States

Site Status ACTIVE_NOT_RECRUITING

UC San Diego Health System - Encinitas

Encinitas, California, United States

Site Status RECRUITING

UC San Diego Moores Cancer Center

La Jolla, California, United States

Site Status RECRUITING

Contra Costa Regional Medical Center

Martinez, California, United States

Site Status RECRUITING

Mercy Cancer Center

Merced, California, United States

Site Status RECRUITING

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, United States

Site Status SUSPENDED

Bay Area Tumor Institute

Oakland, California, United States

Site Status ACTIVE_NOT_RECRUITING

Marshall Hospital

Placerville, California, United States

Site Status RECRUITING

Mercy Cancer Center - Rocklin

Rocklin, California, United States

Site Status RECRUITING

Mercy Cancer Center - Sacramento

Sacramento, California, United States

Site Status RECRUITING

UC San Diego Medical Center - Hillcrest

San Diego, California, United States

Site Status RECRUITING

Pacific Central Coast Health Center-San Luis Obispo

San Luis Obispo, California, United States

Site Status RECRUITING

UCSF Cancer Center - San Mateo

San Mateo, California, United States

Site Status RECRUITING

Mission Hope Medical Oncology - Santa Maria

Santa Maria, California, United States

Site Status RECRUITING

Epic Care Cyberknife Center

Walnut Creek, California, United States

Site Status ACTIVE_NOT_RECRUITING

BASS Medical Group - Lennon

Walnut Creek, California, United States

Site Status RECRUITING

Woodland Memorial Hospital

Woodland, California, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, United States

Site Status RECRUITING

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, United States

Site Status RECRUITING

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

Site Status RECRUITING

Boulder Community Foothills Hospital

Boulder, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers - Centennial

Centennial, Colorado, United States

Site Status RECRUITING

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, United States

Site Status RECRUITING

Saint Francis Cancer Center

Colorado Springs, Colorado, United States

Site Status RECRUITING

UCHealth - Cherry Creek

Denver, Colorado, United States

Site Status RECRUITING

The Women's Imaging Center

Denver, Colorado, United States

Site Status RECRUITING

Porter Adventist Hospital

Denver, Colorado, United States

Site Status SUSPENDED

Colorado Blood Cancer Institute

Denver, Colorado, United States

Site Status SUSPENDED

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Midtown

Denver, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Rose

Denver, Colorado, United States

Site Status RECRUITING

Rose Medical Center

Denver, Colorado, United States

Site Status SUSPENDED

Mercy Medical Center

Durango, Colorado, United States

Site Status RECRUITING

Southwest Oncology PC

Durango, Colorado, United States

Site Status RECRUITING

Mountain Blue Cancer Care Center - Swedish

Englewood, Colorado, United States

Site Status SUSPENDED

Rocky Mountain Cancer Centers - Swedish

Englewood, Colorado, United States

Site Status RECRUITING

Swedish Medical Center

Englewood, Colorado, United States

Site Status SUSPENDED

The Melanoma and Skin Cancer Institute

Englewood, Colorado, United States

Site Status RECRUITING

Poudre Valley Hospital

Fort Collins, Colorado, United States

Site Status RECRUITING

Cancer Care and Hematology-Fort Collins

Fort Collins, Colorado, United States

Site Status RECRUITING

UCHealth Greeley Hospital

Greeley, Colorado, United States

Site Status RECRUITING

UCHealth Highlands Ranch Hospital

Highlands Ranch, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Lakewood

Lakewood, Colorado, United States

Site Status RECRUITING

Saint Anthony Hospital

Lakewood, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Littleton

Littleton, Colorado, United States

Site Status RECRUITING

Littleton Adventist Hospital

Littleton, Colorado, United States

Site Status SUSPENDED

Rocky Mountain Cancer Centers-Sky Ridge

Lone Tree, Colorado, United States

Site Status RECRUITING

Longmont United Hospital

Longmont, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Longmont

Longmont, Colorado, United States

Site Status RECRUITING

Medical Center of the Rockies

Loveland, Colorado, United States

Site Status RECRUITING

Parker Adventist Hospital

Parker, Colorado, United States

Site Status SUSPENDED

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers-Thornton

Thornton, Colorado, United States

Site Status RECRUITING

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status RECRUITING

Mount Sinai Comprehensive Cancer Center at Aventura

Aventura, Florida, United States

Site Status RECRUITING

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Site Status RECRUITING

Mount Sinai Medical Center

Miami Beach, Florida, United States

Site Status RECRUITING

Hawaii Cancer Care Inc - Waterfront Plaza

Honolulu, Hawaii, United States

Site Status ACTIVE_NOT_RECRUITING

Queen's Cancer Cenrer - POB I

Honolulu, Hawaii, United States

Site Status ACTIVE_NOT_RECRUITING

Queen's Medical Center

Honolulu, Hawaii, United States

Site Status ACTIVE_NOT_RECRUITING

Straub Clinic and Hospital

Honolulu, Hawaii, United States

Site Status ACTIVE_NOT_RECRUITING

University of Hawaii Cancer Center

Honolulu, Hawaii, United States

Site Status ACTIVE_NOT_RECRUITING

Hawaii Cancer Care Inc-Liliha

Honolulu, Hawaii, United States

Site Status ACTIVE_NOT_RECRUITING

Hawaii Diagnostic Radiology Services LLC

Honolulu, Hawaii, United States

Site Status ACTIVE_NOT_RECRUITING

Kuakini Medical Center

Honolulu, Hawaii, United States

Site Status ACTIVE_NOT_RECRUITING

Queen's Cancer Center - Kuakini

Honolulu, Hawaii, United States

Site Status ACTIVE_NOT_RECRUITING

The Cancer Center of Hawaii-Liliha

Honolulu, Hawaii, United States

Site Status ACTIVE_NOT_RECRUITING

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

Site Status ACTIVE_NOT_RECRUITING

Straub Medical Center - Kahului Clinic

Kahului, Hawaii, United States

Site Status ACTIVE_NOT_RECRUITING

Castle Medical Center

Kailua, Hawaii, United States

Site Status ACTIVE_NOT_RECRUITING

Wilcox Memorial Hospital and Kauai Medical Clinic

Lihue, Hawaii, United States

Site Status ACTIVE_NOT_RECRUITING

Hawaii Cancer Care - Westridge

‘Aiea, Hawaii, United States

Site Status ACTIVE_NOT_RECRUITING

Pali Momi Medical Center

‘Aiea, Hawaii, United States

Site Status ACTIVE_NOT_RECRUITING

Queen's Cancer Center - Pearlridge

‘Aiea, Hawaii, United States

Site Status ACTIVE_NOT_RECRUITING

Straub Pearlridge Clinic

‘Aiea, Hawaii, United States

Site Status ACTIVE_NOT_RECRUITING

The Cancer Center of Hawaii-Pali Momi

‘Aiea, Hawaii, United States

Site Status ACTIVE_NOT_RECRUITING

The Queen's Medical Center - West Oahu

‘Ewa Beach, Hawaii, United States

Site Status ACTIVE_NOT_RECRUITING

Saint Anthony's Health

Alton, Illinois, United States

Site Status RECRUITING

Rush - Copley Medical Center

Aurora, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Canton

Canton, Illinois, United States

Site Status RECRUITING

Memorial Hospital of Carbondale

Carbondale, Illinois, United States

Site Status RECRUITING

SIH Cancer Institute

Carterville, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Carthage

Carthage, Illinois, United States

Site Status RECRUITING

Centralia Oncology Clinic

Centralia, Illinois, United States

Site Status RECRUITING

Saint Mary's Hospital

Centralia, Illinois, United States

Site Status RECRUITING

John H Stroger Jr Hospital of Cook County

Chicago, Illinois, United States

Site Status RECRUITING

Carle at The Riverfront

Danville, Illinois, United States

Site Status RECRUITING

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Site Status RECRUITING

Decatur Memorial Hospital

Decatur, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Dixon

Dixon, Illinois, United States

Site Status RECRUITING

Carle Physician Group-Effingham

Effingham, Illinois, United States

Site Status RECRUITING

Crossroads Cancer Center

Effingham, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Eureka

Eureka, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Site Status RECRUITING

Western Illinois Cancer Treatment Center

Galesburg, Illinois, United States

Site Status RECRUITING

Ingalls Memorial Hospital

Harvey, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Macomb

Macomb, Illinois, United States

Site Status RECRUITING

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

Site Status RECRUITING

Good Samaritan Regional Health Center

Mount Vernon, Illinois, United States

Site Status RECRUITING

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

Site Status RECRUITING

HSHS Saint Elizabeth's Hospital

O'Fallon, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Pekin

Pekin, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Site Status RECRUITING

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Peru

Peru, Illinois, United States

Site Status RECRUITING

Valley Radiation Oncology

Peru, Illinois, United States

Site Status RECRUITING

Illinois CancerCare-Princeton

Princeton, Illinois, United States

Site Status RECRUITING

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Site Status RECRUITING

Springfield Clinic

Springfield, Illinois, United States

Site Status RECRUITING

Memorial Medical Center

Springfield, Illinois, United States

Site Status RECRUITING

Carle Cancer Center

Urbana, Illinois, United States

Site Status RECRUITING

The Carle Foundation Hospital

Urbana, Illinois, United States

Site Status RECRUITING

Illinois CancerCare - Washington

Washington, Illinois, United States

Site Status RECRUITING

Rush-Copley Healthcare Center

Yorkville, Illinois, United States

Site Status RECRUITING

Reid Health

Richmond, Indiana, United States

Site Status ACTIVE_NOT_RECRUITING

Mary Greeley Medical Center

Ames, Iowa, United States

Site Status RECRUITING

McFarland Clinic - Ames

Ames, Iowa, United States

Site Status RECRUITING

Mission Cancer and Blood - Ankeny

Ankeny, Iowa, United States

Site Status RECRUITING

McFarland Clinic - Boone

Boone, Iowa, United States

Site Status RECRUITING

Saint Anthony Regional Hospital

Carroll, Iowa, United States

Site Status RECRUITING

Mercy Cancer Center-West Lakes

Clive, Iowa, United States

Site Status SUSPENDED

Mission Cancer and Blood - West Des Moines

Clive, Iowa, United States

Site Status SUSPENDED

Alegent Health Mercy Hospital

Council Bluffs, Iowa, United States

Site Status SUSPENDED

Greater Regional Medical Center

Creston, Iowa, United States

Site Status SUSPENDED

Iowa Methodist Medical Center

Des Moines, Iowa, United States

Site Status RECRUITING

Mission Cancer and Blood - Des Moines

Des Moines, Iowa, United States

Site Status RECRUITING

Broadlawns Medical Center

Des Moines, Iowa, United States

Site Status RECRUITING

Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

Site Status SUSPENDED

Mission Cancer and Blood - Laurel

Des Moines, Iowa, United States

Site Status SUSPENDED

Iowa Lutheran Hospital

Des Moines, Iowa, United States

Site Status RECRUITING

McFarland Clinic - Trinity Cancer Center

Fort Dodge, Iowa, United States

Site Status RECRUITING

Trinity Regional Medical Center

Fort Dodge, Iowa, United States

Site Status RECRUITING

McFarland Clinic - Jefferson

Jefferson, Iowa, United States

Site Status RECRUITING

McFarland Clinic - Marshalltown

Marshalltown, Iowa, United States

Site Status RECRUITING

Methodist West Hospital

West Des Moines, Iowa, United States

Site Status RECRUITING

Mercy Medical Center-West Lakes

West Des Moines, Iowa, United States

Site Status SUSPENDED

Central Care Cancer Center - Garden City

Garden City, Kansas, United States

Site Status RECRUITING

Central Care Cancer Center - Great Bend

Great Bend, Kansas, United States

Site Status RECRUITING

Flaget Memorial Hospital

Bardstown, Kentucky, United States

Site Status RECRUITING

Commonwealth Cancer Center-Corbin

Corbin, Kentucky, United States

Site Status RECRUITING

Saint Joseph Hospital

Lexington, Kentucky, United States

Site Status RECRUITING

Saint Joseph Radiation Oncology Resource Center

Lexington, Kentucky, United States

Site Status RECRUITING

Saint Joseph Hospital East

Lexington, Kentucky, United States

Site Status RECRUITING

Saint Joseph London

London, Kentucky, United States

Site Status RECRUITING

Jewish Hospital

Louisville, Kentucky, United States

Site Status SUSPENDED

Saints Mary and Elizabeth Hospital

Louisville, Kentucky, United States

Site Status SUSPENDED

UofL Health Medical Center Northeast

Louisville, Kentucky, United States

Site Status SUSPENDED

Saint Joseph Mount Sterling

Mount Sterling, Kentucky, United States

Site Status RECRUITING

Mercy Health - Paducah Medical Oncology and Hematology

Paducah, Kentucky, United States

Site Status RECRUITING

Jewish Hospital Medical Center South

Shepherdsville, Kentucky, United States

Site Status SUSPENDED

Maine Medical Partners Urology

South Portland, Maine, United States

Site Status RECRUITING

Hickman Cancer Center

Adrian, Michigan, United States

Site Status RECRUITING

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, United States

Site Status RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, United States

Site Status RECRUITING

Trinity Health Medical Center - Brighton

Brighton, Michigan, United States

Site Status RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, United States

Site Status RECRUITING

Trinity Health Medical Center - Canton

Canton, Michigan, United States

Site Status RECRUITING

Caro Cancer Center

Caro, Michigan, United States

Site Status RECRUITING

Chelsea Hospital

Chelsea, Michigan, United States

Site Status RECRUITING

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, United States

Site Status RECRUITING

Hematology Oncology Consultants-Clarkston

Clarkston, Michigan, United States

Site Status RECRUITING

Newland Medical Associates-Clarkston

Clarkston, Michigan, United States

Site Status RECRUITING

Ascension Saint John Hospital

Detroit, Michigan, United States

Site Status RECRUITING

Great Lakes Cancer Management Specialists-Doctors Park

East China, Michigan, United States

Site Status SUSPENDED

Genesee Cancer and Blood Disease Treatment Center

Flint, Michigan, United States

Site Status RECRUITING

Genesee Hematology Oncology PC

Flint, Michigan, United States

Site Status RECRUITING

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Site Status RECRUITING

Hurley Medical Center

Flint, Michigan, United States

Site Status RECRUITING

Academic Hematology Oncology Specialists

Grosse Pointe Woods, Michigan, United States

Site Status SUSPENDED

Great Lakes Cancer Management Specialists-Van Elslander Cancer Center

Grosse Pointe Woods, Michigan, United States

Site Status SUSPENDED

Michigan Breast Specialists-Grosse Pointe Woods

Grosse Pointe Woods, Michigan, United States

Site Status SUSPENDED

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, United States

Site Status RECRUITING

Hope Cancer Clinic

Livonia, Michigan, United States

Site Status SUSPENDED

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, United States

Site Status RECRUITING

Great Lakes Cancer Management Specialists-Macomb Medical Campus

Macomb, Michigan, United States

Site Status SUSPENDED

Michigan Breast Specialists-Macomb Township

Macomb, Michigan, United States

Site Status SUSPENDED

Saint Mary's Oncology/Hematology Associates of Marlette

Marlette, Michigan, United States

Site Status RECRUITING

Toledo Clinic Cancer Centers-Monroe

Monroe, Michigan, United States

Site Status RECRUITING

Hope Cancer Center

Pontiac, Michigan, United States

Site Status RECRUITING

Michigan Healthcare Professionals Pontiac

Pontiac, Michigan, United States

Site Status RECRUITING

Newland Medical Associates-Pontiac

Pontiac, Michigan, United States

Site Status RECRUITING

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, United States

Site Status RECRUITING

Ascension Saint Mary's Hospital

Saginaw, Michigan, United States

Site Status RECRUITING

Oncology Hematology Associates of Saginaw Valley PC

Saginaw, Michigan, United States

Site Status RECRUITING

Bhadresh Nayak MD PC-Sterling Heights

Sterling Heights, Michigan, United States

Site Status SUSPENDED

Ascension Saint Joseph Hospital

Tawas City, Michigan, United States

Site Status RECRUITING

Advanced Breast Care Center PLLC

Warren, Michigan, United States

Site Status SUSPENDED

Great Lakes Cancer Management Specialists-Macomb Professional Building

Warren, Michigan, United States

Site Status SUSPENDED

Macomb Hematology Oncology PC

Warren, Michigan, United States

Site Status SUSPENDED

Michigan Breast Specialists-Warren

Warren, Michigan, United States

Site Status SUSPENDED

Saint John Macomb-Oakland Hospital

Warren, Michigan, United States

Site Status RECRUITING

Saint Mary's Oncology/Hematology Associates of West Branch

West Branch, Michigan, United States

Site Status RECRUITING

Huron Gastroenterology PC

Ypsilanti, Michigan, United States

Site Status RECRUITING

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, United States

Site Status RECRUITING

Fairview Ridges Hospital

Burnsville, Minnesota, United States

Site Status SUSPENDED

Minnesota Oncology - Burnsville

Burnsville, Minnesota, United States

Site Status RECRUITING

Cambridge Medical Center

Cambridge, Minnesota, United States

Site Status RECRUITING

Mercy Hospital

Coon Rapids, Minnesota, United States

Site Status RECRUITING

Fairview Southdale Hospital

Edina, Minnesota, United States

Site Status RECRUITING

Unity Hospital

Fridley, Minnesota, United States

Site Status ACTIVE_NOT_RECRUITING

Fairview Clinics and Surgery Center Maple Grove

Maple Grove, Minnesota, United States

Site Status RECRUITING

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, United States

Site Status RECRUITING

Saint John's Hospital - Healtheast

Maplewood, Minnesota, United States

Site Status RECRUITING

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Site Status RECRUITING

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status RECRUITING

Health Partners Inc

Minneapolis, Minnesota, United States

Site Status RECRUITING

Monticello Cancer Center

Monticello, Minnesota, United States

Site Status RECRUITING

New Ulm Medical Center

New Ulm, Minnesota, United States

Site Status RECRUITING

Fairview Northland Medical Center

Princeton, Minnesota, United States

Site Status RECRUITING

North Memorial Medical Health Center

Robbinsdale, Minnesota, United States

Site Status RECRUITING

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Site Status RECRUITING

Regions Hospital

Saint Paul, Minnesota, United States

Site Status RECRUITING

United Hospital

Saint Paul, Minnesota, United States

Site Status RECRUITING

Saint Francis Regional Medical Center

Shakopee, Minnesota, United States

Site Status RECRUITING

Lakeview Hospital

Stillwater, Minnesota, United States

Site Status RECRUITING

Ridgeview Medical Center

Waconia, Minnesota, United States

Site Status RECRUITING

Rice Memorial Hospital

Willmar, Minnesota, United States

Site Status RECRUITING

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, United States

Site Status RECRUITING

Fairview Lakes Medical Center

Wyoming, Minnesota, United States

Site Status RECRUITING

Saint Louis Cancer and Breast Institute-Ballwin

Ballwin, Missouri, United States

Site Status RECRUITING

Central Care Cancer Center - Bolivar

Bolivar, Missouri, United States

Site Status RECRUITING

Cox Cancer Center Branson

Branson, Missouri, United States

Site Status RECRUITING

Saint Francis Medical Center

Cape Girardeau, Missouri, United States

Site Status RECRUITING

Southeast Cancer Center

Cape Girardeau, Missouri, United States

Site Status RECRUITING

Parkland Health Center - Farmington

Farmington, Missouri, United States

Site Status RECRUITING

MU Health Care Goldschmidt Cancer Center

Jefferson City, Missouri, United States

Site Status SUSPENDED

Freeman Health System

Joplin, Missouri, United States

Site Status RECRUITING

Mercy Hospital Joplin

Joplin, Missouri, United States

Site Status RECRUITING

Lake Regional Hospital

Osage Beach, Missouri, United States

Site Status RECRUITING

Delbert Day Cancer Institute at PCRMC

Rolla, Missouri, United States

Site Status RECRUITING

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, United States

Site Status RECRUITING

Heartland Regional Medical Center

Saint Joseph, Missouri, United States

Site Status RECRUITING

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, United States

Site Status RECRUITING

Mercy Hospital Springfield

Springfield, Missouri, United States

Site Status RECRUITING

CoxHealth South Hospital

Springfield, Missouri, United States

Site Status RECRUITING

Saint Louis Cancer and Breast Institute-South City

St Louis, Missouri, United States

Site Status RECRUITING

Mercy Hospital South

St Louis, Missouri, United States

Site Status RECRUITING

Missouri Baptist Medical Center

St Louis, Missouri, United States

Site Status RECRUITING

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Site Status RECRUITING

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, United States

Site Status RECRUITING

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, United States

Site Status RECRUITING

Mercy Hospital Washington

Washington, Missouri, United States

Site Status RECRUITING

Nebraska Cancer Specialists/Oncology Hematology West PC

Grand Island, Nebraska, United States

Site Status SUSPENDED

CHI Health Good Samaritan

Kearney, Nebraska, United States

Site Status RECRUITING

Saint Elizabeth Regional Medical Center

Lincoln, Nebraska, United States

Site Status SUSPENDED

Alegent Health Immanuel Medical Center

Omaha, Nebraska, United States

Site Status RECRUITING

Alegent Health Bergan Mercy Medical Center

Omaha, Nebraska, United States

Site Status RECRUITING

Alegent Health Lakeside Hospital

Omaha, Nebraska, United States

Site Status RECRUITING

Creighton University Medical Center

Omaha, Nebraska, United States

Site Status RECRUITING

Midlands Community Hospital

Papillion, Nebraska, United States

Site Status SUSPENDED

New Hampshire Oncology Hematology PA-Concord

Concord, New Hampshire, United States

Site Status RECRUITING

Solinsky Center for Cancer Care

Manchester, New Hampshire, United States

Site Status RECRUITING

Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status RECRUITING

Saint Peter's University Hospital

New Brunswick, New Jersey, United States

Site Status ACTIVE_NOT_RECRUITING

University of New Mexico Cancer Center

Albuquerque, New Mexico, United States

Site Status RECRUITING

Elmhurst Hospital Center

Elmhurst, New York, United States

Site Status SUSPENDED

Queens Hospital Center

Jamaica, New York, United States

Site Status RECRUITING

James J Peters VA Medical Center

The Bronx, New York, United States

Site Status RECRUITING

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Site Status RECRUITING

Outer Banks Hospital

Nags Head, North Carolina, United States

Site Status RECRUITING

Indu and Raj Soin Medical Center

Beavercreek, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Saint Elizabeth Boardman Hospital

Boardman, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Dayton Physicians LLC-Miami Valley South

Centerville, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Miami Valley Hospital South

Centerville, Ohio, United States

Site Status SUSPENDED

Good Samaritan Hospital - Cincinnati

Cincinnati, Ohio, United States

Site Status RECRUITING

Oncology Hematology Care Inc-Kenwood

Cincinnati, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Bethesda North Hospital

Cincinnati, Ohio, United States

Site Status RECRUITING

TriHealth Cancer Institute-Westside

Cincinnati, Ohio, United States

Site Status RECRUITING

TriHealth Cancer Institute-Anderson

Cincinnati, Ohio, United States

Site Status RECRUITING

Miami Valley Hospital

Dayton, Ohio, United States

Site Status SUSPENDED

Dayton Physician LLC - Englewood

Dayton, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Miami Valley Hospital North

Dayton, Ohio, United States

Site Status SUSPENDED

Armes Family Cancer Center

Findlay, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Blanchard Valley Hospital

Findlay, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Orion Cancer Care

Findlay, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Atrium Medical Center-Middletown Regional Hospital

Franklin, Ohio, United States

Site Status SUSPENDED

Dayton Physicians LLC-Atrium

Franklin, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Dayton Physicians LLC-Wayne

Greenville, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Wayne Hospital

Greenville, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Greater Dayton Cancer Center

Kettering, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Kettering Medical Center

Kettering, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Toledo Clinic Cancer Centers-Maumee

Maumee, Ohio, United States

Site Status RECRUITING

Springfield Regional Cancer Center

Springfield, Ohio, United States

Site Status SUSPENDED

Springfield Regional Medical Center

Springfield, Ohio, United States

Site Status SUSPENDED

Mercy Health - Saint Anne Hospital

Toledo, Ohio, United States

Site Status SUSPENDED

Toledo Clinic Cancer Centers-Toledo

Toledo, Ohio, United States

Site Status RECRUITING

Dayton Physicians LLC - Troy

Troy, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Upper Valley Medical Center

Troy, Ohio, United States

Site Status SUSPENDED

Saint Joseph Warren Hospital

Warren, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Saint Elizabeth Youngstown Hospital

Youngstown, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Oregon Health and Science University

Portland, Oregon, United States

Site Status RECRUITING

Portland VA Medical Center

Portland, Oregon, United States

Site Status RECRUITING

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, United States

Site Status RECRUITING

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, United States

Site Status RECRUITING

Pocono Medical Center

East Stroudsburg, Pennsylvania, United States

Site Status RECRUITING

Lehigh Valley Hospital-Hazleton

Hazleton, Pennsylvania, United States

Site Status RECRUITING

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Reading Hospital

West Reading, Pennsylvania, United States

Site Status RECRUITING

Ralph H Johnson VA Medical Center

Charleston, South Carolina, United States

Site Status RECRUITING

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status RECRUITING

Lexington Medical Center

West Columbia, South Carolina, United States

Site Status RECRUITING

Saint Joseph Regional Cancer Center

Bryan, Texas, United States

Site Status SUSPENDED

Audie L Murphy VA Hospital

San Antonio, Texas, United States

Site Status RECRUITING

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status TERMINATED

Inova Alexandria Hospital

Alexandria, Virginia, United States

Site Status RECRUITING

Chesapeake Regional Medical Center

Chesapeake, Virginia, United States

Site Status RECRUITING

Inova Schar Cancer Institute

Fairfax, Virginia, United States

Site Status RECRUITING

Inova Fair Oaks Hospital

Fairfax, Virginia, United States

Site Status RECRUITING

Inova Fairfax Hospital

Falls Church, Virginia, United States

Site Status RECRUITING

Sovah Health Martinsville

Martinsville, Virginia, United States

Site Status RECRUITING

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, United States

Site Status ACTIVE_NOT_RECRUITING

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, United States

Site Status ACTIVE_NOT_RECRUITING

Highline Medical Center-Main Campus

Burien, Washington, United States

Site Status SUSPENDED

Saint Elizabeth Hospital

Enumclaw, Washington, United States

Site Status SUSPENDED

Saint Francis Hospital

Federal Way, Washington, United States

Site Status SUSPENDED

Saint Clare Hospital

Lakewood, Washington, United States

Site Status SUSPENDED

Jefferson Healthcare

Port Townsend, Washington, United States

Site Status RECRUITING

Saint Michael Cancer Center

Silverdale, Washington, United States

Site Status RECRUITING

Franciscan Research Center-Northwest Medical Plaza

Tacoma, Washington, United States

Site Status SUSPENDED

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, United States

Site Status RECRUITING

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin, United States

Site Status RECRUITING

Cancer Center of Western Wisconsin

New Richmond, Wisconsin, United States

Site Status RECRUITING

Cheyenne Regional Medical Center-West

Cheyenne, Wyoming, United States

Site Status SUSPENDED

FHP Health Center-Guam

Tamuning, , Guam

Site Status ACTIVE_NOT_RECRUITING

Cancer Center-Metro Medical Center Bayamon

Bayamón, , Puerto Rico

Site Status RECRUITING

Puerto Rico Hematology Oncology Group

Bayamón, , Puerto Rico

Site Status RECRUITING

Doctors Cancer Center

Manatí, , Puerto Rico

Site Status RECRUITING

San Juan Community Oncology Group

San Juan, , Puerto Rico

Site Status RECRUITING

Centro Comprensivo de Cancer de UPR

San Juan, , Puerto Rico

Site Status RECRUITING

PROncology

San Juan, , Puerto Rico

Site Status RECRUITING

San Juan City Hospital

San Juan, , Puerto Rico

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Guam Puerto Rico

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

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Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2020-07173

Identifier Type: REGISTRY

Identifier Source: secondary_id

EA8184

Identifier Type: OTHER

Identifier Source: secondary_id

ECOG-ACRIN-EA8184

Identifier Type: OTHER

Identifier Source: secondary_id

EA8184

Identifier Type: OTHER

Identifier Source: secondary_id

UG1CA189828

Identifier Type: NIH

Identifier Source: secondary_id

View Link

EA8184

Identifier Type: -

Identifier Source: org_study_id