Detecting HPV DNA in Anal and Cervical Cancers

Part of paid clinical trials in Chicago, Illinois.

Sponsor
University of Chicago
Study ID
NCT04857528
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Oct 6, 2020
Status verified
Mar 2026
Primary completion
Nov 15, 2027
Completion
Nov 15, 2027

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: 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).
  • Arm: 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.

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of ChicagoChicagoIllinois60637
Clinical Trials Intake
[email protected]
855-702-8222
Christina Son, MD (PRINCIPAL_INVESTIGATOR)
University of Illinois at ChicagoChicagoIllinois60612
Meredith Russell
[email protected]
Christina Son (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By condition
Cervical cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
University of Chicago· Chicago, ILUniversity of Illinois at Chicago· Chicago, IL

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