Cervical Cancer Clinical Trial
Official title:
Circulating HPV DNA in Cancers of the Anus and Uterine Cervix Treated With Definitive Radiation Therapy
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | November 15, 2027 |
Est. primary completion date | November 15, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Chicago | Chicago | Illinois |
United States | University of Illinois at Chicago | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Chicago |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Accuracy of HPV DNA Levels in Predicting Cancer Recurrence at 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. | 24 months |
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