S1204, Viral Screening in Newly Diagnosed Cancer Patients

Completed

Conditions: Cancer

Registration Number: NCT01946516

Lead Sponsor: SWOG Cancer Research Network

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 3051

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

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With Positive Viral Infection	Up to 21 days after registration	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.

Secondary Outcome Measures

Name	Time	Method
Presence of Important Risk Factors in Participants Tested for HIV	Up to 21 days after registration	The presence or absence of specific risk factors among participants evaluated for HIV is evaluated.
Presence of Important Risk Factors in Participants Tested for Chronic HBV	Up to 21 days after registration	The presence or absence of specific risk factors among participants evaluated for chronic HBV is evaluated.
Cost-effectiveness of Viral Screening	3 years after registration	Estimate the cost-effectiveness of screening for HIV, HBV, and HCV.
Type and Rate of Adverse Events Among Patients With Viral Infection.	5 years after registration	Estimate type and rate of cancer-treatment related adverse events among persons with HIV, HBV, and/or HCV infection.
Presence of Important Risk Factors in Participants Tested for Previous HBV	Up to 21 days after registration	The presence or absence of specific risk factors among participants evaluated for previous HBV is evaluated.
Type of Treatment for Cancer and Virus in Participants With Positive Viral Test	60 days after registration	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.
Presence of Important Risk Factors in Participants Tested for HCV	Up to 21 days after registration	The presence or absence of specific risk factors among participants evaluated for HCV is evaluated.

Trial Locations

Locations (58): 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
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Kaiser Permanente Hospital
🇺🇸Fontana, California, United States