Study Results
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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RECRUITING
1600 participants
OBSERVATIONAL
2020-11-11
2027-04-30
Brief Summary
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Detailed Description
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I. To support current and future investigations into drug resistance and sensitivity and other National Cancer Institute (NCI)-sponsored cancer research initiatives through the procurement and distribution of multiple longitudinal biospecimens and associated data from a diverse group of cancer patients who are undergoing standard of care treatment at NCI Community Oncology Research Program (NCORP) sites and other National Clinical Trials Network (NCTN) sites.
SECONDARY OBJECTIVES:
I. To provide a service of value to study participants and their medical providers through the performance of molecular profiling assays on tumor samples in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory and reporting of results to physicians and patients that they may opt to use in clinical management, including analysis of data for acquired resistance mechanisms.
II. To enable the development of patient-derived models such as cell lines and xenografts for cancer researchers through the provision of biospecimens from up to 20% of study participants to the NCI's Patient Derived Models Repository (PDMR), a national resource available to investigators.
III. To develop and implement robust approaches in patient and provider engagement to improve understanding of biobanking and its relationship to cancer research and increase representation of minority and underserved study participants in cancer research.
IV. To develop increased capabilities in United States (U.S.) community hospitals and clinics for contribution to cancer research through biobanking activities.
V. To enable secondary research generated from the project through deposition of data in public repositories such as Cancer Research Data Commons (CRDC), The Cancer Imaging Archive (TCIA) and database of Genotypes and Phenotypes (dbGaP) and other potential NCI databases, including clinical, radiology and pathology data with an emphasis on treatment response and outcome data.
VI. To provide residual biospecimens and associated data from the project to the cancer research community.
OUTLINE:
Patients undergo collection of tissue samples during baseline and at time of disease progression and collection of blood samples throughout the study, including at time of disease progression. Patients with hematological malignancies also undergo collection of bone marrow and cerebral spinal fluid at the same time points. Archival blood and tissue, as well as bone marrow of patients with hematological malignancies, is also collected if available. Additionally, patients may undergo computed tomography (CT), positron emission tomography (PET)/CT and/or magnetic resonance imaging (MRI) throughout the study, and may undergo paracentesis on study. Patient medical records are reviewed, and data is collected for at least 5 years.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Observational (biospecimen collection, chart review)
Patients undergo collection of tissue samples during baseline and at time of disease progression and collection of blood samples throughout the study, including at time of disease progression. Patients with hematological malignancies also undergo collection of bone marrow and cerebral spinal fluid at the same time points. Archival blood and tissue, as well as bone marrow of patients with hematological malignancies, is also collected if available. Additionally, patients may undergo CT, PET/CT and/or MRI throughout the study, and may undergo paracentesis on study. Patient medical records are reviewed, and data is collected for at least 5 years.
Biospecimen Collection
Undergo collection of blood, tissue, bone marrow, and cerebral spinal fluid samples
Computed Tomography
Undergo CT
Magnetic Resonance Imaging
Undergo MRI
Medical Chart Review
Medical charts are reviewed and data is collected
Paracentesis
Undergo paracentesis
Positron Emission Tomography
Undergo PET/CT
Interventions
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Biospecimen Collection
Undergo collection of blood, tissue, bone marrow, and cerebral spinal fluid samples
Computed Tomography
Undergo CT
Magnetic Resonance Imaging
Undergo MRI
Medical Chart Review
Medical charts are reviewed and data is collected
Paracentesis
Undergo paracentesis
Positron Emission Tomography
Undergo PET/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Colorectal cancer: stage IV
* Non-small cell or small cell lung cancer: stage III/IV
* Prostate cancer: metastatic prostate cancer
* Gastric cancer, not otherwise specified (NOS): stage IV
* Esophageal cancer, NOS: stage IV
* Adenocarcinoma of gastroesophageal junction: stage IV
* High grade serous ovarian cancer: stage III/IV
* Invasive breast carcinoma: stage III/IV
* Melanoma: stage III/IV
* Acute myeloid leukemia
* Multiple myeloma
* For the purposes of this study,
* Re-staging is allowed
* Having more than one primary cancer is allowed, if the patient is being treated solely for one of the eligible cancers listed above
* Patient should fit in one of the following four clinical scenarios (a-d)
* Undergoing diagnostic workup for one of the diseases listed for which treatment will likely include a new regimen of standard of care therapy OR
* Scheduled to begin treatment with a new regimen of standard of care therapy OR
* Currently progressing on a regimen of standard of care therapy OR
* Currently being treated with a regimen standard of care therapy, without evidence of progression
* Requirements for fresh tissue biospecimen collections at enrollment:
* For clinical scenarios a, b, and c above, freshly collected tumor tissue or bone marrow (BM) aspirate must be submitted at enrollment
* For clinical scenarios a and b, the fresh tissue collection must be prior to starting therapy
* For clinical scenario a, the biospecimen collection must be part of a standard of care medical procedure
* For clinical scenarios b or c, the biospecimen collection may be part of a standard of care medical procedure OR
* The biospecimen collection may be part of a study-specific procedure ("research only biopsy"), when the patient has a tumor amenable to image guided or direct vision biopsy and is willing and able to undergo a tumor biopsy for molecular profiling
* Note: For research-only biopsies, the biopsy must not be associated with a significant risk of severe or major complications or death; the procedure cannot be a mediastinal, laparoscopic, open or endoscopic biopsy; nor can the procedure be a brain biopsy; nor can the patient be under the age of majority as determined by each U.S. state
* Requirements for archival tissue:
* For clinical scenarios a and b above, archival tissue as outlined below must be submitted IF AVAILABLE
* For clinical scenarios c and d above, archival tissue as outlined below is REQUIRED
* Pre-existing archival material (formalin-fixed, paraffin-embedded \[FFPE\] block, BM aspirate, or unstained slides) that:
* Contains the cancer type for which the participant is enrolled, and
* Was collected no more than 5 years prior to initiation of therapy, and
* Contains at least a surface area of 5 mm\^2 and optimal surface area of 25 mm\^2 or 3-5 mL cryopreserved bone marrow aspirate to yield 200 million bone marrow mononuclear cells, and
* Contains at least 10% tumor content. 70% tumor content is optimal, and
* No more than 1 line of standard of care systemic therapy was administered from the date of archival material collection to the date of initiation of therapy
* Requirements for blood collection: ALL scenarios require fresh blood collection at enrollment
* Blood collection for clinical scenarios a, b, and c must take place within 1 week of fresh tumor specimen collection
* Blood collection for clinical scenario d must take place within 4 weeks of enrollment, and while patient is on treatment
* Age 13 or older
* Any sex
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2
* Ability to understand and willingness to sign an informed consent document. Consent may be provided by a Legally Authorized Representative (LAR) in accordance with 45 CFR 46.102(i)
* Any race/ethnicity with hormone receptor positive (ER+PR+, ER+PR-, or ER-PR+)
* African American with triple negative (ER-PR-HER2-)
Exclusion Criteria
* For the purposes of this study, past enrollment in clinical trials whereby the patient was randomized and treated with standard-of-care anti-cancer treatment (chemotherapy regimen, surgery and radiation therapy) is allowed
* Uncontrolled intercurrent illness that in the physician's assessment would pose undue risk for biopsy
* Use of full dose coumarin-derivative anticoagulants such as warfarin are prohibited. Patients may be switched to low molecular weight (LMW) heparin at physician discretion
* Low molecular weight (LMW) heparin is permitted for prophylactic or therapeutic use
* Factor X inhibitors are permitted
* Use of anti-platelet drugs are permitted
* Stopping the anticoagulation treatment for biopsy, bone marrow aspirate, or resection should be per site standard operating procedure (SOP)
* Actively febrile patients with uncertain etiology of febrile episode
* All antibiotics for non-prophylactic treatment of infection should be completed at least 1 week (7 days) prior to collection
* No recurrence of fever or other symptoms related to infection for at least 1 week (7 days) following completion of antibiotics
13 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Lyndsay N Harris
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)
Locations
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Gulf Health Hospitals Inc/Infirmary Cancer Care - Malbis
Daphne, Alabama, United States
Thomas Hospital
Fairhope, Alabama, United States
Mobile Infirmary Medical Center
Mobile, Alabama, United States
Gulf Health Hospitals Inc/Infirmary Cancer Care - Saraland
Saraland, Alabama, United States
Kingman Regional Medical Center
Kingman, Arizona, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States
PCR Oncology
Arroyo Grande, California, United States
AIS Cancer Center at San Joaquin Community Hospital
Bakersfield, California, United States
Veterans Affairs Loma Linda Healthcare System
Loma Linda, California, United States
Salinas Valley Memorial
Salinas, California, United States
Intermountain Health Platte Valley Hospital
Brighton, Colorado, United States
Saint Joseph Hospital - Cancer Centers of Colorado
Denver, Colorado, United States
Lutheran Hospital - Cancer Centers of Colorado
Golden, Colorado, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States
Good Samaritan Hospital - Cancer Centers of Colorado
Lafayette, Colorado, United States
Hartford Hospital
Hartford, Connecticut, United States
Bayhealth Hospital Kent Campus
Dover, Delaware, United States
Bayhealth Hospital Sussex Campus
Milford, Delaware, United States
Boca Raton Regional Hospital
Boca Raton, Florida, United States
Broward Health North
Deerfield Beach, Florida, United States
Broward Health Medical Center
Fort Lauderdale, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Northside Hospital
Atlanta, Georgia, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, United States
Swedish Covenant Hospital
Chicago, Illinois, United States
Carle at The Riverfront
Danville, Illinois, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, United States
Decatur Memorial Hospital
Decatur, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, United States
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois, United States
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States
SSM Health Good Samaritan
Mount Vernon, Illinois, United States
Illinois CancerCare-Pekin
Pekin, Illinois, United States
Illinois CancerCare-Peoria
Peoria, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Illinois CancerCare - Washington
Washington, Illinois, United States
McFarland Clinic - Ames
Ames, Iowa, United States
University of Iowa Healthcare Cancer Services Quad Cities
Bettendorf, Iowa, United States
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, United States
Oncology Associates at Mercy Medical Center
Cedar Rapids, Iowa, United States
Blank Children's Hospital
Des Moines, Iowa, United States
Iowa Methodist Medical Center
Des Moines, Iowa, United States
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana, United States
University Medical Center New Orleans
New Orleans, Louisiana, United States
Children's Hospital New Orleans
New Orleans, Louisiana, United States
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, United States
Harold Alfond Center for Cancer Care
Augusta, Maine, United States
MaineHealth Waldo Hospital
Belfast, Maine, United States
MaineHealth Maine Medical Center - Biddeford
Biddeford, Maine, United States
MaineHealth Cancer Care and IV Therapy - Brunswick
Brunswick, Maine, United States
Mid Coast Hospital
Brunswick, Maine, United States
MaineHealth LincolnHealth Hospital
Damariscotta, Maine, United States
MaineHealth Franklin Hospital
Farmington, Maine, United States
Saint Mary's Regional Medical Center
Lewiston, Maine, United States
MaineHealth Stephens Hospital
Norway, Maine, United States
Maine Medical Partners Surgical Care
Portland, Maine, United States
MaineHealth Maine Medical Center - Portland
Portland, Maine, United States
MMP Surgical Care Casco Bay
Portland, Maine, United States
Penobscot Bay Medical Center
Rockport, Maine, United States
MaineHealth Cancer Care and IV Therapy - Sanford
Sanford, Maine, United States
Maine Children's Cancer Program
Scarborough, Maine, United States
Maine Medical Partners Neurology
Scarborough, Maine, United States
MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine, United States
MaineHealth Cancer Care and IV Therapy - South Portland
South Portland, Maine, United States
MaineHealth Urology - South Portland
South Portland, Maine, United States
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Ann Arbor, Michigan, United States
Trinity Health Medical Center - Brighton
Brighton, Michigan, United States
Trinity Health Medical Center - Canton
Canton, Michigan, United States
Chelsea Hospital
Chelsea, Michigan, United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, United States
Dickinson County Healthcare System
Iron Mountain, Michigan, United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan, United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan, United States
Mercy Oncology and Hematology - Clayton-Clarkson
Ballwin, Missouri, United States
Freeman Health System
Joplin, Missouri, United States
Mercy Hospital Joplin
Joplin, Missouri, United States
Mercy Clinic-Rolla-Cancer and Hematology
Rolla, Missouri, United States
Phelps Health Delbert Day Cancer Institute
Rolla, Missouri, United States
Heartland Regional Medical Center
Saint Joseph, Missouri, United States
Mercy Hospital Springfield
Springfield, Missouri, United States
CoxHealth South Hospital
Springfield, Missouri, United States
Mercy Infusion Center - Chippewa
St Louis, Missouri, United States
Mercy Hospital South
St Louis, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
Mercy Hospital Saint Louis
St Louis, Missouri, United States
Mercy Hospital Washington
Washington, Missouri, United States
Saint Vincent Frontier Cancer Center
Billings, Montana, United States
Saint James Community Hospital and Cancer Treatment Center
Butte, Montana, United States
Nebraska Cancer Specialists/Oncology Hematology West PC
Grand Island, Nebraska, United States
Carson Tahoe Regional Medical Center
Carson City, Nevada, United States
OptumCare Cancer Care at Seven Hills
Henderson, Nevada, United States
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, United States
Hope Cancer Care of Nevada
Las Vegas, Nevada, United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, United States
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, United States
Saint Joseph Hospital
Nashua, New Hampshire, United States
Morristown Medical Center
Morristown, New Jersey, United States
Newton Medical Center
Newton, New Jersey, United States
Chilton Medical Center
Pompton, New Jersey, United States
Overlook Hospital
Summit, New Jersey, United States
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Montefiore Medical Center-Einstein Campus
The Bronx, New York, United States
Montefiore Medical Center-Weiler Hospital
The Bronx, New York, United States
Children's Hospital at Montefiore
The Bronx, New York, United States
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States
Novant Health Presbyterian Medical Center
Charlotte, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
ECU Health Medical Center
Greenville, North Carolina, United States
Novant Health Cancer Institute - Kernersville
Kernersville, North Carolina, United States
ECU Health Oncology Kinston
Kinston, North Carolina, United States
Novant Health Cancer Institute - Mount Airy
Mount Airy, North Carolina, United States
FirstHealth of the Carolinas-Moore Regional Hospital
Pinehurst, North Carolina, United States
Novant Health Cancer Institute - Thomasville
Thomasville, North Carolina, United States
Marion L Shepard Cancer Center - ECU Health Beaufort Hospital
Washington, North Carolina, United States
Novant Health Forsyth Medical Center
Winston-Salem, North Carolina, United States
Mercy Hospital Oklahoma City
Oklahoma City, Oklahoma, United States
Roger Williams Medical Center
Providence, Rhode Island, United States
Prisma Health Richland Hospital
Columbia, South Carolina, United States
Prisma Health Baptist Hospital
Columbia, South Carolina, United States
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, United States
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, United States
Gibbs Cancer Center-Pelham
Greer, South Carolina, United States
Spartanburg Medical Center
Spartanburg, South Carolina, United States
SMC Center for Hematology Oncology Union
Union, South Carolina, United States
Audie L Murphy VA Hospital
San Antonio, Texas, United States
Centra Alan B Pearson Regional Cancer Center
Lynchburg, Virginia, United States
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States
Valley Medical Center
Renton, Washington, United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington, United States
Edwards Comprehensive Cancer Center
Huntington, West Virginia, United States
Monongalia Hospital
Morgantown, West Virginia, United States
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States
Aurora Saint Luke's Medical Center
Milwaukee, Wisconsin, United States
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, United States
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, United States
Marshfield Medical Center - Weston
Weston, Wisconsin, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, United States
San Juan Community Oncology Group
San Juan, , Puerto Rico
Centro Comprensivo de Cancer de UPR
San Juan, , Puerto Rico
San Juan City Hospital
San Juan, , Puerto Rico
Countries
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Facility Contacts
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Other Identifiers
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NCI-2020-00750
Identifier Type: REGISTRY
Identifier Source: secondary_id
10323
Identifier Type: OTHER
Identifier Source: secondary_id
10323
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2020-00750
Identifier Type: -
Identifier Source: org_study_id
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