S1204, Viral Screening in Newly Diagnosed Cancer Patients

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.

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.)