Finding HPV DNA in the blood of people with anal or cervical cancer.
Circulating HPV DNA in Cancers of the Anus and Uterine Cervix Treated With Definitive Radiation Therapy
This study will test whether a blood test can find HPV DNA in people with HPV-related anal or cervical cancer before, during, and after radiation treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Chicago Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT04857528 on ClinicalTrials.gov |
What this trial studies
This observational study enrolls adults with p16-positive anal or cervical cancer who are planned for definitive radiation, with or without chemotherapy. Blood samples will be collected before, during, and after radiation and analyzed with HPV genotyping to detect circulating HPV DNA. Archival tumor tissue and additional blood specimens will be stored for future laboratory testing to explore tumor biology and treatment response. Participation lasts about two years and involves multiple site visits for blood draws and clinical data collection.
Who should consider this trial
Good fit: Adults (≥18 years) with p16-positive stage I–III anal cancer or stage I–IVA cervical cancer who are planned for definitive radiation therapy, with or without concurrent systemic therapy.
Not a fit: Patients whose tumors are not p16-positive, who have HPV types outside the targeted genotypes (not 16, 18, 31, 33, or 35), or who are receiving only adjuvant/postoperative radiation are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, a simple blood test could help track HPV-related tumors and provide an earlier, less invasive signal of how patients are responding to radiation.
How similar studies have performed: Previous studies detecting circulating HPV DNA in HPV-related cancers have shown promising signals for monitoring disease, but routine clinical adoption remains limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chicago, Illinois and 1 other locations
- University of Illinois at Chicago — Chicago, Illinois, United States (Recruiting)
- University of Chicago — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Christina Son, MD — University of Chicago
- Study coordinator: Christina Son, MD
- Email: cson@radonc.uchicago.edu
- Phone: 773-702-6870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.