S1204, Viral Screening in Newly Diagnosed Cancer Patients

• Prevalence of viral infection [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  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.
  
  

• Risk factor evaluation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  Risk factors will be evaluated comparing all infections (within virus), known infections, and undiagnosed infections. Moreover, risk factors will be evaluated within tumor type, although our ability to make inferences within tumor types will be limited by relatively small numbers.
  
  
• Timing and type of treatment for cancer and virus. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  Among patients with HIV, HBV, or HCV, evaluate timing and type of treatments received, both for the viral infections and the cancers.
  
  
• Type and rage of Adverse Events among patients with viral infection. [ Time Frame: 2 ] [ Designated as safety issue: No ]
  Estimate type and rate of cancer-treatment related adverse events among persons with HIV, HBV, and/or HCV infection.
  
  
• Cost-effectiveness of viral screening [ Time Frame: 3 year ] [ Designated as safety issue: No ]
  Estimate the cost-effectiveness of screening for HIV, HBV, and HCV.
  
  

• Create biorepository of stored serum for future research. [ Time Frame: 2 ] [ Designated as safety issue: No ]
  Create a biorepository of stored serum for the purposes of identifying genomic and viral factors that increase the risk of serious adverse effects among HIV, HBV and HCV infected persons being treated for cancer.
  
  

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.