Actively Recruiting
Circulating HPV DNA in Anal and Cervical Cancers Treated With Radiation Therapy
Led by University of Chicago · Updated on 2026-03-04
20
Participants Needed
2
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying individuals with human papillomavirus (HPV)-associated anal and cervical cancers who are receiving radiation treatment as part of their standard cancer care. The study aims to detect HPV DNA in the blood before, during, and after radiation therapy. The research also involves testing archival tumor tissue from previous biopsies to gather more information about HPV-related cancers and their response to treatment. This observational study is sponsored by the University of Chicago and involves both retrospective and prospective participant groups. Participants fall into two groups: those who have already completed chemoradiation for their HPV-related cancer before the study began, and those who will receive radiation treatment during the study period. Blood samples will be collected multiple times from prospective participants, while retrospective participants provide previously collected blood and tumor tissue samples. The study evaluates circulating HPV DNA through blood tests and tumor tissue analysis without requiring new biopsies. Participants will be followed for approximately two years, with blood samples collected before, during, and after treatment to monitor HPV DNA levels. Researchers will also perform physical exams, which may include anoscopy or sigmoidoscopy, about 12 months after radiation treatment. Imaging scans such as PET or CT scans may be used to assess the cancer. The primary outcome is the rate of participants with detectable circulating HPV DNA, and secondary outcomes include evaluating HPV DNA levels to predict cancer recurrence at 24 months.
CONDITIONS
Brief Title
Detecting HPV DNA in Anal and Cervical Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of stage I-III anal cancer or stage I-IVA cervical cancer that is positive for p16 based on immunohistochemistry
- Age 18 years or older
- Planned to receive radiation therapy as the main treatment, with or without chemotherapy
You will not qualify if you...
- Anal cancer not linked to HPV types 16, 18, 31, 33, or 35
- Planned to receive radiation therapy only as additional or post-operative treatment
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of radiation treatment (varies per participant)
Participants receive radiation treatment with or without chemotherapy as their main treatment for HPV-related anal or cervical cancer. Blood samples are collected before, during, and after radiation treatment to detect circulating HPV DNA.
Multiple visits during treatment for radiation and blood sample collection
Duration - Up to 12 months after treatment
Participants undergo blood sample collection and diagnostic tests including PET/CT scans and physical exams (which may include anoscopy or sigmoidoscopy) approximately 12 months after radiation treatment to monitor HPV DNA levels and cancer status.
Approximately 1 to 2 visits post-treatment
Duration - Up to 25 months
Participants are observed for up to 24-25 months to assess the rate of detectable circulating HPV DNA and accuracy of HPV DNA levels in predicting cancer recurrence.
Visit frequency varies; includes monitoring through medical record review and potential additional sample collections
Trial Site Locations
Total: 2 locations
1
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Actively Recruiting
2
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
Research Team
C
Christina Son, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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