S1204, Viral Screening in Newly Diagnosed Cancer Patients

NCT ID: NCT01946516

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3051 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-08-29
• Study Completion Date: 2022-10-13

Brief Summary

The goal of this study is to estimate the prevalence of HIV, Hepatitis B and hepatitis C infection among newly diagnosed cancer patients presenting to community and academic oncology clinics.

Detailed Description

Primary Objective

Among newly diagnosed cancer patients presenting to SWOG-affiliated community and academic oncology clinics, estimate the prevalence of human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) infection. Prevalence estimates will be further stratified: by whether infection with the virus(es) is known, as reported by patients and/or their physician prior to study testing, vs. unknown; by presenting cancer type, and by self-reported risk factors for each virus.

Secondary Objectives

• Evaluate known sociodemographic, clinical, and behavioral factors that are significantly associated with previously undiagnosed HIV, HBV, and/or HCV infection in a population of people with newly diagnosed cancer.
• Among patients who are identified as having HIV, HBV, and/or HCV, evaluate the timing and type of treatments received, both for the viral infections and the cancers.
• Evaluate type and rate of cancer treatment-related adverse events in patients with HIV, HBV, and/or HCV infection.
• Using simulation modeling that is directly informed by the data obtained from this study, determine the cost-effectiveness (expressed as cost per infection detected and cost per year of life gained) of (1) routine, universal screening and (2) risk factor-directed screening of newly diagnosed cancer patients for HIV, HBV, and/or HCV vs. current care.

Tertiary Objective

Create a biorepository of stored serum for future translational medicine studies that may include identifying genomic and viral factors that increase the risk of serious adverse effects among participants infected with HIV, HBV, and/or HCV being treated for invasive cancers.

Conditions

Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• presenting for evaluation or treatment of a new cancer malignancy(including hematologic)
• confirmed pathologic diagnosis must be within 120 days of registration (Patients presenting for "second opinions" of confirmed malignancies are eligible, including those who have started cancer treatment at other facilities)
• at least 18 years of age
• patient must have had their blood drawn for HIV, HBV and HCV testing prior to registration (Patients who have had HIV, HBV and/or HCV testing within 60 days prior to registration and who do not wish to be retested are eligible, provided supporting documents can be obtained confirming viral test results for all three viruses. Documentation must be obtained prior to registration.

Patients who are viral positive for either HIV, HBV, and/or HCV and who do not wish to be retested are eligible, provided documentation of viral load within 120 days prior to registration can be obtained. Note that these patients must be tested for or provide current viral load for all three viruses to be eligible. Documentation must be obtained prior to registration.)

• Patients must sign and give written informed consent in accordance with institutional and federal guidelines
• Patients must be offered the opportunity to allow their blood specimens to be banked by the SWOG Repository for future research

Exclusion Criteria

• diagnosed with a malignancy other than the current malignancy within the past five years (with the exception of basal cell or squamous cell skin cancer, in situ cervical cancer, or in situ breast cancer.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

SWOG Cancer Research Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott D. Ramsey, M.D.

Role: STUDY_CHAIR

Fred Hutchinson Cancer Center

Locations

Kaiser Permanente Hospital

Fontana, California, United States

Kaiser Permanente - Harbor City

Harbor City, California, United States

Contra Costa Regional Medical Center

Martinez, California, United States

East Bay Physicians Medical Group-Summit

Oakland, California, United States

Kaiser Permanente-Oakland

Oakland, California, United States

Desert Regional Medical Center

Palm Springs, California, United States

Kaiser Permanente - Panorama City

Panorama City, California, United States

Kaiser Permanente-Roseville

Roseville, California, United States

Kaiser Permanente-San Francisco

San Francisco, California, United States

Kaiser Permanente Medical Center-Vacaville

Vacaville, California, United States

Kaiser Permanente-Lone Tree

Lone Tree, Colorado, United States

University of Hawaii Cancer Center

Honolulu, Hawaii, United States

Tripler Army Medical Center

Honolulu, Hawaii, United States

Saint Luke's Mountain States Tumor Institute - Meridian

Meridian, Idaho, United States

Mac Neal Hospital

Berwyn, Illinois, United States

Weiss Memorial Hospital

Chicago, Illinois, United States

Hines Veterans Administration Hospital

Hines, Illinois, United States

West Suburban Medical Center

River Forest, Illinois, United States

Veteran Administration Eastern Kansas Healthcare

Leavenworth, Kansas, United States

Topeka VA Hospital

Topeka, Kansas, United States

LSU Health Baton Rouge-North Clinic

Baton Rouge, Louisiana, United States

Louisiana Hematology Oncology Associates LLC

Baton Rouge, Louisiana, United States

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

Medical Oncology LLC

Baton Rouge, Louisiana, United States

Mary Bird Cancer Center/Saint Tammany Parish

Covington, Louisiana, United States

Women's Cancer Care-Covington

Covington, Louisiana, United States

Mary Bird Perkins Cancer Center/Terrebonne General Medical Center

Houma, Louisiana, United States

Oncology Center of The South Incorporated

Houma, Louisiana, United States

East Jefferson General Hospital

Metairie, Louisiana, United States

University Health-Conway

Monroe, Louisiana, United States

University Medical Center New Orleans

New Orleans, Louisiana, United States

Louisiana State University Health Sciences Center Shreveport

Shreveport, Louisiana, United States

North Shore Hematology Oncology Associates Inc

Slidell, Louisiana, United States

Boston Medical Center

Boston, Massachusetts, United States

Kansas City Veterans Affairs Medical Center

Kansas City, Missouri, United States

Billings Clinic Cancer Center

Billings, Montana, United States

Saint James Community Hospital and Cancer Treatment Center

Butte, Montana, United States

Columbia University/Herbert Irving Cancer Center

New York, New York, United States

Adena Regional Medical Center

Chillicothe, Ohio, United States

Columbus Oncology and Hematology Associates Inc

Columbus, Ohio, United States

Grant Medical Center

Columbus, Ohio, United States

OneHealth Marion General Hospital

Marion, Ohio, United States

Knox Community Hospital

Mount Vernon, Ohio, United States

Licking Memorial Hospital

Newark, Ohio, United States

Southern Ohio Medical Center

Portsmouth, Ohio, United States

Kaiser Permanente Northwest

Portland, Oregon, United States

Greenville Health System Cancer Institute-Andrews

Greenville, South Carolina, United States

Greenville Health System Cancer Institute-Butternut

Greenville, South Carolina, United States

Greenville Health System Cancer Institute-Faris

Greenville, South Carolina, United States

Greenville Memorial Hospital

Greenville, South Carolina, United States

Greenville Health System Cancer Institute-Eastside

Greenville, South Carolina, United States

Greenville Health System Cancer Institute-Greer

Greer, South Carolina, United States

Greenville Health System Cancer Institute-Seneca

Seneca, South Carolina, United States

Greenville Health System Cancer Institute-Spartanburg

Spartanburg, South Carolina, United States

The Don and Sybil Harrington Cancer Center

Amarillo, Texas, United States

Lyndon Baines Johnson General Hospital

Houston, Texas, United States

Audie L Murphy Veterans Affairs Hospital

San Antonio, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

NCI-2013-01631

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA032102

Identifier Type: NIH

Identifier Source: secondary_id

View Link

S1204

Identifier Type: -

Identifier Source: org_study_id