Finding HPV DNA in the blood of people with anal or cervical cancer.
Official title: Circulating HPV DNA in Cancers of the Anus and Uterine Cervix Treated With Definitive Radiation Therapy
Run by University of Chicago · NCT04857528 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | University of Chicago Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Status | Recruiting |
| Started | October 6, 2020 |
| Main results expected | November 15, 2027 |
| Study ends | November 15, 2027 |
| Registry record updated | March 4, 2026 |
| Trial ID | NCT04857528 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies detecting circulating HPV DNA in HPV-related cancers have shown promising signals for monitoring disease, but routine clinical adoption remains limited.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.