S1204, Viral Screening in Newly Diagnosed Cancer Patients
- 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
- 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
- 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 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 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.
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.
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.
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.
Trial Locations
- Locations (58)
Louisiana State University Health Sciences Center Shreveport
🇺🇸Shreveport, Louisiana, United States
Mary Bird Perkins Cancer Center
🇺🇸Baton Rouge, Louisiana, United States
Greenville Health System Cancer Institute-Spartanburg
🇺🇸Spartanburg, South Carolina, United States
Columbus Oncology and Hematology Associates Inc
🇺🇸Columbus, Ohio, United States
Weiss Memorial Hospital
🇺🇸Chicago, Illinois, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Kaiser Permanente - Harbor City
🇺🇸Harbor City, California, United States
Kaiser Permanente-Oakland
🇺🇸Oakland, California, United States
Tripler Army Medical Center
🇺🇸Honolulu, Hawaii, United States
Saint Luke's Mountain States Tumor Institute - Meridian
🇺🇸Meridian, Idaho, United States
Contra Costa Regional Medical Center
🇺🇸Martinez, California, United States
Louisiana Hematology Oncology Associates LLC
🇺🇸Baton Rouge, Louisiana, United States
Kaiser Permanente - Panorama City
🇺🇸Panorama City, California, United States
Hines Veterans Administration Hospital
🇺🇸Hines, Illinois, United States
Kaiser Permanente-Lone Tree
🇺🇸Lone Tree, Colorado, United States
Veteran Administration Eastern Kansas Healthcare
🇺🇸Leavenworth, Kansas, United States
Topeka VA Hospital
🇺🇸Topeka, Kansas, United States
Oncology Center of The South Incorporated
🇺🇸Houma, Louisiana, United States
Adena Regional Medical Center
🇺🇸Chillicothe, Ohio, United States
LSU Health Baton Rouge-North Clinic
🇺🇸Baton Rouge, 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
University Medical Center New Orleans
🇺🇸New Orleans, Louisiana, United States
Greenville Health System Cancer Institute-Eastside
🇺🇸Greenville, South Carolina, United States
Medical Oncology LLC
🇺🇸Baton Rouge, Louisiana, United States
Licking Memorial Hospital
🇺🇸Newark, Ohio, United States
Grant Medical Center
🇺🇸Columbus, Ohio, United States
Kaiser Permanente Medical Center-Vacaville
🇺🇸Vacaville, California, United States
Kaiser Permanente Hospital
🇺🇸Fontana, California, United States
Kaiser Permanente-Roseville
🇺🇸Roseville, California, United States
West Suburban Medical Center
🇺🇸River Forest, Illinois, 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
East Bay Physicians Medical Group-Summit
🇺🇸Oakland, California, United States
Desert Regional Medical Center
🇺🇸Palm Springs, California, United States
University of Hawaii Cancer Center
🇺🇸Honolulu, Hawaii, United States
Mac Neal Hospital
🇺🇸Berwyn, Illinois, United States
North Shore Hematology Oncology Associates Inc
🇺🇸Slidell, Louisiana, United States
Southern Ohio Medical Center
🇺🇸Portsmouth, Ohio, United States
Lyndon Baines Johnson General Hospital
🇺🇸Houston, Texas, United States
The Don and Sybil Harrington Cancer Center
🇺🇸Amarillo, 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
Kaiser Permanente-San Francisco
🇺🇸San Francisco, California, United States
Kaiser Permanente Northwest
🇺🇸Portland, Oregon, United States
Mary Bird Cancer Center/Saint Tammany Parish
🇺🇸Covington, Louisiana, United States
East Jefferson General Hospital
🇺🇸Metairie, Louisiana, United States
University Health-Conway
🇺🇸Monroe, Louisiana, United States
Kansas City Veterans Affairs Medical Center
🇺🇸Kansas City, Missouri, United States
Billings Clinic Cancer Center
🇺🇸Billings, Montana, United States
OneHealth Marion General Hospital
🇺🇸Marion, Ohio, United States
Knox Community Hospital
🇺🇸Mount Vernon, Ohio, 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-Greer
🇺🇸Greer, South Carolina, United States
Greenville Health System Cancer Institute-Seneca
🇺🇸Seneca, South Carolina, United States