Detecting HPV DNA in Anal and Cervical Cancers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radiation Treatment With or Without Chemotherapy, Blood Sample Collection, HPV Genotyping (HPV DNA Test), Testing Archival Tumor Tissue.
- Who it may be relevant to
- Registry conditions: Cervical Cancer, Anal Cancer, HPV-Related Anal Squamous Cell Carcinoma, HPV-Related Cervical Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Circulating HPV DNA in Cancers of the Anus and Uterine Cervix Treated With Definitive Radiation Therapy
Overview
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.
Interventions
- Radiation Radiation Treatment With or Without Chemotherapy
Standard care radiation treatment. - Other 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. - Diagnostic test 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. - Diagnostic test 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. - Other 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). - Diagnostic test 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 measures
- Rate of Participants With Detectable Circulating HPV DNA in Blood/Tumor Samples [Time frame: 25 months]
Secondary outcome measures (1)
- Accuracy of HPV DNA Levels in Predicting Cancer Recurrence at 24 Months [Time frame: 24 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 2 centers
- University of Illinois at Chicago — Chicago
- University of Chicago — Chicago
Identifiers
NCT: NCT04857528 · IRB20-0410