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NCT Number: NCT04857528

Detecting HPV DNA in Anal and Cervical Cancers

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.

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Key information

Conditions

Cervical Cancer Anal Cancer Anus Diseases Anus Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female HPV-Related Anal Squamous Cell Carcinoma HPV-Related Carcinoma HPV-Related Cervical Carcinoma Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Cervical Cancer Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Chicago, Chicago, Illinois, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Radiation Treatment With or Without Chemotherapy

Radiation

Standard care radiation treatment.

Blood Sample Collection

Other

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.

HPV Genotyping (HPV DNA Test)

Diagnostic Test

A test used to detect the type of HPV DNA found in the participant's blood and tumor tissue samples.

Testing Archival Tumor Tissue

Diagnostic Test

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.

physical exam

Other

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).

Positron Emission Tomography Scan (PET Scan)/ Computed Tomography Scan (CT Scan)

Diagnostic Test

Tests that use computers and/or rotating x-rays to scan/create images of the body.

Primary outcomes

  1. Rate of Participants With Detectable Circulating HPV DNA in Blood/Tumor Samples

    Time frame: 25 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.

Secondary outcomes

  1. Accuracy of HPV DNA Levels in Predicting Cancer Recurrence at 24 Months

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Christina Son, MD

CONTACT

[email protected]

773-702-6870

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Apr 23, 2021
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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