Detecting HPV DNA in Anal and Cervical Cancers
Circulating HPV DNA in Cancers of the Anus and Uterine Cervix Treated With Definitive Radiation Therapy
1 other identifier
observational
20
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2020
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 6, 2020
CompletedFirst Submitted
Initial submission to the registry
April 8, 2021
CompletedFirst Posted
Study publicly available on registry
April 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 15, 2027
March 4, 2026
March 1, 2026
7.1 years
April 8, 2021
March 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of Participants With Detectable Circulating HPV DNA in Blood/Tumor Samples
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.
25 months
Secondary Outcomes (1)
Accuracy of HPV DNA Levels in Predicting Cancer Recurrence at 24 Months
24 months
Study Arms (2)
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
Standard care radiation treatment.
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.
A test used to detect the type of HPV DNA found in the participant's blood and tumor tissue samples.
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.
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).
Tests that use computers and/or rotating x-rays to scan/create images of the body.
Eligibility Criteria
Participants will be identified and selected from patients receiving treatment in the Departments of Radiation Oncology at University of Chicago and all participating sites where this study is being conducted including. Individuals from the public who have an HPV-associated cancer and fit the listed inclusion criteria can also be considered for participation in this study.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
University of Chicago
Chicago, Illinois, 60637, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christina Son, MD
University of Chicago
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2021
First Posted
April 23, 2021
Study Start
October 6, 2020
Primary Completion (Estimated)
November 15, 2027
Study Completion (Estimated)
November 15, 2027
Last Updated
March 4, 2026
Record last verified: 2026-03