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Observational Study: Detecting HPV DNA in Anal and Cervical Cancers

This research study is for people with anal or cervical cancer that is linked to human papillomavirus (HPV) and who are receiving radiation treatment, with or without chemotherapy. Doctors want to see if they can find HPV DNA in your blood before, during, and after your radiation treatment. They will also test blood and leftover tumor tissue (from a previous biopsy) to learn more about how HPV-related cancers respond to treatment. You may be able to join if you are at least 18 years old, have Stage I-III anal cancer or Stage I-IVA cervical cancer that is p16 positive, and are planning to have radiation therapy. The main goal is to see how many participants have detectable HPV DNA in their blood or tumor samples. The current recruitment status is unclear.

Study design
This is an observational study with a planned enrollment of 20 participants. It is not specified if it is randomized or blinded.
What's involved
You would have blood samples collected before, during, and after radiation treatment, and a physical exam 12 months after treatment, which may include an anoscopy or sigmoidoscopy. Your participation would last approximately 2 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for approximately 25 months to measure the rate of detectable circulating HPV DNA in blood/tumor samples.

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NCT04857528

Detecting HPV DNA in Anal and Cervical Cancers

Recruiting
Not specifiedAges 18+Observational
University of Chicago
~20 participants
Updated 2026-03-04 on ClinicalTrials.gov
What's tested:Radiation Treatment With or Without ChemotherapyBlood Sample CollectionHPV Genotyping (HPV DNA Test)Testing Archival Tumor TissuePhysical ExamPositron Emission Tomography Scan (PET Scan)/ Computed Tomography Scan (CT Scan)

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of Participants With Detectable Circulating HPV DNA in Blood/Tumor Samples
Measured over 25 months

Conditions

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

Explore related trials

Anal CarcinomaCervical CarcinomaSolid NeoplasmCDKN2A wt AlleleHPV

Where it's being run

2 sites across 1 states
Illinois2

Study leadership

  • Christina Son, MD · PRINCIPAL_INVESTIGATOR · University of Chicago

Who to contact

Christina Son, MD
[email protected]
773-702-6870
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Rate of Participants With Detectable Circulating HPV DNA in Blood/Tumor Samples25 months

    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.