RecruitingNCT04857528

Detecting HPV DNA in Anal and Cervical Cancers

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


Sponsor

University of Chicago

Enrollment

20 participants

Start Date

Oct 6, 2020

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking HPV DNA (genetic material from the virus) in the blood of people being treated for anal or cervical cancer linked to HPV, to see whether blood-based HPV testing can predict treatment success. **You may be eligible if...** - You have been diagnosed with stage I–III anal cancer or stage I–IVA cervical cancer that tested positive for p16 (a marker for HPV-related cancer) - You are 18 years or older - You are planning to receive radiation therapy as your primary treatment (with or without chemotherapy) **You may NOT be eligible if...** - Your anal cancer is not linked to HPV types 16, 18, 31, 33, or 35 - You are receiving radiation as a follow-up after surgery rather than as the main treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONRadiation Treatment With or Without Chemotherapy

Standard care radiation treatment.

OTHERBlood 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_TESTHPV 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_TESTTesting 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.

OTHERPhysical 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_TESTPositron 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.


Locations(2)

University of Illinois at Chicago

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

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NCT04857528


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