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NCT01946516 Clinical Trial

S1204, Viral Screening in Newly Diagnosed Cancer Patients

Cancer Clinical Trial

Official title:
A Sero-Epidemiologic Survey and Cost Effectiveness Study of Screening for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) Among Newly Diagnosed Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01946516
Other study ID # S1204
Secondary ID NCI-2013-01631U1
Status Completed
Phase
First received
Last updated
Start date August 29, 2013
Est. completion date October 13, 2022

Study information
Verified date June 2023
Source SWOG Cancer Research Network
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 3051
Est. completion date October 13, 2022
Est. primary completion date January 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States The Don and Sybil Harrington Cancer Center Amarillo Texas
United States Louisiana Hematology Oncology Associates LLC Baton Rouge Louisiana
United States LSU Health Baton Rouge-North Clinic Baton Rouge Louisiana
United States Mary Bird Perkins Cancer Center Baton Rouge Louisiana
United States Medical Oncology LLC Baton Rouge Louisiana
United States Mac Neal Hospital Berwyn Illinois
United States Billings Clinic Cancer Center Billings Montana
United States Boston Medical Center Boston Massachusetts
United States Saint James Community Hospital and Cancer Treatment Center Butte Montana
United States Weiss Memorial Hospital Chicago Illinois
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 Mary Bird Cancer Center/Saint Tammany Parish Covington Louisiana
United States Women's Cancer Care-Covington Covington Louisiana
United States Kaiser Permanente Hospital Fontana California
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-Eastside 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-Greer Greer South Carolina
United States Kaiser Permanente - Harbor City Harbor City California
United States Hines Veterans Administration Hospital Hines Illinois
United States Tripler Army Medical Center Honolulu Hawaii
United States University of Hawaii Cancer Center Honolulu Hawaii
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 Lyndon Baines Johnson General Hospital Houston Texas
United States Kansas City Veterans Affairs Medical Center Kansas City Missouri
United States Veteran Administration Eastern Kansas Healthcare Leavenworth Kansas
United States Kaiser Permanente-Lone Tree Lone Tree Colorado
United States OneHealth Marion General Hospital Marion Ohio
United States Contra Costa Regional Medical Center Martinez California
United States Saint Luke's Mountain States Tumor Institute - Meridian Meridian Idaho
United States East Jefferson General Hospital Metairie Louisiana
United States University Health-Conway Monroe Louisiana
United States Knox Community Hospital Mount Vernon Ohio
United States University Medical Center New Orleans New Orleans Louisiana
United States Columbia University/Herbert Irving Cancer Center New York New York
United States Licking Memorial Hospital Newark Ohio
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 Northwest Portland Oregon
United States Southern Ohio Medical Center Portsmouth Ohio
United States West Suburban Medical Center River Forest Illinois
United States Kaiser Permanente-Roseville Roseville California
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 Kaiser Permanente-San Francisco San Francisco California
United States Greenville Health System Cancer Institute-Seneca Seneca South Carolina
United States Louisiana State University Health Sciences Center Shreveport Shreveport Louisiana
United States North Shore Hematology Oncology Associates Inc Slidell Louisiana
United States Greenville Health System Cancer Institute-Spartanburg Spartanburg South Carolina
United States Topeka VA Hospital Topeka Kansas
United States Kaiser Permanente Medical Center-Vacaville Vacaville California

Sponsors (2)
Lead Sponsor Collaborator
SWOG Cancer Research Network National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants With Positive Viral Infection An estimate of the prevalence of human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) infection among newly diagnosed cancer participants presenting to SWOG-affiliated community and academic oncology clinics. Up to 21 days after registration
Secondary Presence of Important Risk Factors in Participants Tested for Previous HBV The presence or absence of specific risk factors among participants evaluated for previous HBV is evaluated. Up to 21 days after registration
Secondary Presence of Important Risk Factors in Participants Tested for Chronic HBV The presence or absence of specific risk factors among participants evaluated for chronic HBV is evaluated. Up to 21 days after registration
Secondary Presence of Important Risk Factors in Participants Tested for HCV The presence or absence of specific risk factors among participants evaluated for HCV is evaluated. Up to 21 days after registration
Secondary Presence of Important Risk Factors in Participants Tested for HIV The presence or absence of specific risk factors among participants evaluated for HIV is evaluated. Up to 21 days after registration
Secondary Type of Treatment for Cancer and Virus in Participants With Positive Viral Test Among participants with HIV, HBV, or HCV, the timing and type of treatments received, both for the viral infections and the cancers that were evaluated. 60 days after registration
Secondary Type and Rate of Adverse Events Among Patients With Viral Infection. Estimate type and rate of cancer-treatment related adverse events among persons with HIV, HBV, and/or HCV infection. 5 years after registration
Secondary Cost-effectiveness of Viral Screening Estimate the cost-effectiveness of screening for HIV, HBV, and HCV. 3 years after registration
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