NCT04857528

Detecting HPV DNA in Anal and Cervical Cancers

Circulating HPV DNA in Cancers of the Anus and Uterine Cervix Treated With Definitive Radiation Therapy

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: University of Chicago · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cervical Cancer
• Anal Cancer
• HPV-Related Anal Squamous Cell Carcinoma
• HPV-Related Cervical Carcinoma
• HPV-Related Carcinoma
• Uterine Cervical Cancer

Interventions

Type	Name	Description
RADIATION	Radiation Treatment With or Without Chemotherapy	Standard care radiation treatment.
OTHER	Blood Sample Collection	Researchers 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.
DIAGNOSTIC_TEST	HPV Genotyping (HPV DNA Test)	A test used to detect the type of HPV DNA found in the participant's blood and tumor tissue samples.
DIAGNOSTIC_TEST	Testing Archival Tumor Tissue	Tumor 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.
OTHER	Physical Exam	A 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).
DIAGNOSTIC_TEST	Positron Emission Tomography Scan (PET Scan)/ Computed Tomography Scan (CT Scan)	Tests that use computers and/or rotating x-rays to scan/create images of the body.

Timeline

• Start date: 2020-10-06
• Primary completion: 2027-11-15
• Completion: 2027-11-15
• First posted: 2021-04-23
• Last updated: 2026-03-04

Locations

2 sites across 1 country: United States