This is a research study for individuals who have cancer associated with human papillomavirus (HPV) and are being treated with radiation as part of standard care for their cancer. Doctors leading this study will use blood tests to find out if they can detect the HPV virus in the blood of study participants before, during, and after radiation treatment. They will also collect blood and archival tumor tissue (from a previous biopsy) to perform other tests in the future that could provide more information about HPV-associated cancers and how they respond to treatment. Participation in this study will last approximately 2 years.
Stage I-III anal cancer or stage I-IVA cervical cancer that is p16+ based on immunohistochemistry.
Age ≥ 18 years
Planned to undergo radiation therapy as definitive treatment, with or without concurrent systemic therapy
Anal carcinoma not associated with HPV-16, 18, 31, 33, or 35 will be removed from the
Planned to undergo radiation therapy as an adjuvant or post-operative therapy
Participants will be identified and selected from patients receiving treatment in the Departments of Radiation Oncology at University of Chicago and all participating sites where this study is being conducted including. Individuals from the public who have an HPV-associated cancer and fit the listed inclusion criteria can also be considered for participation in this study.
Case-only
Prospective
Radiation Treatment With or Without Chemotherapy
RadiationStandard care radiation treatment.
Blood Sample Collection
Other interventionResearchers will collect blood samples from participants before, during and after radiation treatment. Approximately 6 teaspoons of blood will be collected each time blood is drawn.
HPV Genotyping (HPV DNA Test)
Diagnostic testA test used to detect the type of HPV DNA found in the participant's blood and tumor tissue samples.
Testing Archival Tumor Tissue
Diagnostic testTumor tissue will be tested in a lab for all cervical cancer participants and some participants with anal cancer as assessed by the lead study doctor. This tumor tissue sample will be from a previous biopsy that the participant received before the study per standard care; no new biopsy will be required for this study.
Physical Exam
Other interventionA physical exam will be given 12 months after radiation treatment. This physical exam may also include an anoscopy (a procedure to examine the anus using a device inserted into the anus) or sigmoidoscopy (a procedure that looks at the rectum and lower part of the colon using a device inserted into the anus).
Positron Emission Tomography Scan (PET Scan)/ Computed Tomography Scan (CT Scan)
Diagnostic testTests that use computers and/or rotating x-rays to scan/create images of the body.
Rate of Participants With Detectable Circulating HPV DNA in Blood/Tumor Samples
The rate of participants who have detectable HPV DNA in their blood and tumor samples as assessed by analyzing blood/ tumor tissue samples using Polymerase chain reaction (PCR) tests.
Accuracy of HPV DNA Levels in Predicting Cancer Recurrence at 24 Months
The accuracy of post-treatment HPV DNA levels in predicting cancer recurrence at 24 months after treatment. This accuracy will be assessed using statistical calculations incorporating data from the participant's HPV DNA detection test results and clinical records.
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