Blood and cervical HPV DNA/RNA testing to track treatment response in cervical cancer
Official title: Using Plasma Human Papillomavirus (HPV)-Related Deoxyribonucleic Acid (DNA) and Ribonucleic Acid (RNA) to Follow Response of Cervical Cancer to Surgery, Radiation, and Chemotherapy
Run by University of Florida · NCT07214584 · Data updated 2026-11-12
This 9-month study will test two blood-based HPV tests (NavDx and Quantivirus) to see if they can track how adults with HPV-related cervical cancer respond to surgery, radiation, and chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 89 Years |
| Sex | Women only |
| Enrollment | 55 (estimated) |
| Sponsor | University of Florida Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Gainesville, Florida) |
| Status | Recruiting |
| Started | December 15, 2025 |
| Main results expected | September 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | February 12, 2026 |
| Trial ID | NCT07214584 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 and older with HPV-associated squamous, adenocarcinoma, or adenosquamous cervical cancer (AJCC stage I or higher) who have evaluable disease on imaging and agree to serial blood and cervical mucus sampling are ideal candidates.
✕Probably not a fit
Patients without HPV-associated tumors, without evaluable disease, with a concurrent cancer needing therapy, or who cannot comply with follow-up or sampling are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational feasibility project will collect serial blood and cervical mucus samples from adults with HPV-associated cervical cancer before and after standard treatments and compare two commercial assays (NavDx PCR-based and Quantivirus branched DNA/mRNA). Results from the HPV assays will be compared side-by-side with standard imaging and clinical outcomes to see how well the tests reflect treatment response and minimal residual disease. The primary goal is to determine if NavDx can predict personalized tumor response; a secondary goal is to compare Quantivirus performance with NavDx. The study is conducted at the University of Florida over approximately nine months of follow-up.
Why it matters
Potential benefit: If successful, these tests could allow earlier and more sensitive detection of residual or recurrent disease and help personalize post-treatment follow-up.
How similar studies have gone: Prior research on circulating HPV DNA in HPV-related cancers has shown promising sensitivity for detecting residual disease and recurrence, but direct side-by-side comparisons of these commercial assays remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years and older * HPV-associated squamous cell, adenocarcinoma, or adenosquamous cancers of the uterine cervix with evaluable disease * Diagnosed with American Joint Committee on Cancer (AJCC) stage I or higher, or metastatic disease. * Presence of evaluable disease on pre-treatment standard of care imaging with plans to obtain serial post-treatment standard of care imaging * Agree to perform the required research-related blood tests and cervical mucous testing. Exclusion Criteria: * Unable to consent or refusal to sign a consent form * Not meet any inclusion criteria * Unable to comply with follow up scheduling. * Diagnosed with a synchronous malignancy requiring cancer-directed therapy
Where it's running
-
University of Florida
Gainesville, Florida, United States Recruiting
Study contacts
- Study coordinator: Kari S Bastow, BS
- Email: kari.bastow@ufhealth.org
- Phone: 352-265-8827
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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.