Recruiting

HPV with Radiation

Sponsor:

University of Chicago

Code:

NCT04857528

Conditions

Cervical Cancer

Anal Cancer

HPV-Related Anal Squamous Cell Carcinoma

HPV-Related Cervical Carcinoma

HPV-Related Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Radiation Treatment With or Without Chemotherapy

Blood Sample Collection

HPV Genotyping (HPV DNA Test)

Testing Archival Tumor Tissue

Physical Exam

Study Details

Brief 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

Study ID

NCT04857528

Start date

Oct 6, 2020

Status verified date

Mar, 2026

Completion date

Nov 15, 2027

Anticipated

Primary completion date

Nov 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Retrospective (Participants Who Have Already Been Treated for HPV-Related Cancer Before Study)

This group will use medical records from participants who have already received chemoradiation for their HPV-related anal or cervical cancer at a time before this study started. Because they have already received treatment, these participants will provide previous blood/tumor tissue samples that contain detectable HPV DNA as well as at least one post-treatment sample that their doctor collected before the study. Data from these previously collected samples will be compared to current samples from participants who are actively enrolled in this study in present day (chart review).

Prospective (Participants Who Will Receive Radiation Treatment for HPV-Related Cancer During Study)

This group is for participants who plan to receive radiation treatment (with or without chemotherapy) for their HPV-related anal or cervical cancer during the time this study will be conducted. Participants in this group will sign a consent form allowing researchers to collect their blood samples and analyze/compare them to the samples from the retrospective group of participants.

Interventions

Radiation Treatment With or Without Chemotherapy

Standard care radiation treatment.

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.

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.

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.

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).

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.

Primary outcome measure

  • Rate of Participants With Detectable Circulating HPV DNA in Blood/Tumor Samples [ Time Frame: 25 months ]

Central Contacts and Locations

Central contacts

Christina Son, MD

773-702-6870cson@radonc.uchicago.edu

Locations

University of Illinois at Chicago

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Meredith Russell

mrussel3@uic.edu

Principal Investigator:

Christina Son

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Clinical Trials Intake

855-702-8222cancerclinicaltrials@bsd.uchicago.edu

Principal Investigator:

Christina Son, MD

More Information

Sponsor

University of Chicago

Last update posted

Mar 4, 2026

Last verified

Mar, 2026

Keywords

  • HPV
  • radiation treatment
  • cervical cancer
  • anal cancer
  • uterine cervix

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-03-04.