Using Plasma HPV Related DNA and RNA to Follow Response of Cervical Cancer to Surgery, Radiation, and Chemotherapy

Not yet recruiting

• Conditions: Cervical Cancer; Human Papilloma Virus (HPV)

• Registration Number: NCT07214584
• Lead Sponsor: University of Florida

Brief Summary

The goal of this study is to test two commercially available technologies for their ability to detect treatment response in patients with cervical cancer following surgery, radiation, and chemotherapy: one based on PCR (NavDx) and the other on branched DNA (Quantivirus HPV \[DNA\]). We will perform a 9-month feasibility study to examine the side-by-side utility of both NavDx and Quantivirus HPV DNA assays in predicting cervical cancer treatment response.

We believe these tests could prove to be highly sensitive methods for evaluating minimal residual disease and for quantitation of response to surgery, radiation, and chemotherapy in patients with cervical cancer.

Primary Goal:

Feasibility for NavDx HPV DNA assay (Naveris, Inc) to be used for personalized prediction of tumor response before and after treatment.

Secondary Goals:

1. Comparability of the Quantivirus HPV DNA/mRNA assay (DiaCarta, Inc) with the NavDx HPV DNA assay and,

2. Feasibility of the Quantivirus technology for measuring treatment response within the first day to 2 weeks of radiation, surgery, or a new chemotherapy.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-10-01
• Study First Submitted: 2025-10-07
• Study First Submitted QC: 2025-10-07
• Last Update Submitted: 2025-10-07
• Study First Posted: 2025-10-09
• Last Update Posted: 2025-10-09
• Primary Completion: 2026-09-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 55

Inclusion Criteria

• 18 years and older
• HPV-associated squamous cell, adenocarcinoma, or adenosquamous cancers of the uterine cervix with evaluable disease
• Diagnosed with AJCC stage I or higher, or any patient being treated for 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of Circulating HPV DNA/mRNA Liquid Biopsy for Evaluating Treatment Response in Cervical Cancer	From enrollment to the end of the first surveillance visit, which occurs at 3-4 months post op or post-chemo, or at the patient's 3-4 month follow-up radiation therapy visit.	This is a feasibility study to determine the sensitivity of circulating HPV DNA/mRNA, measured by either or both NavDx or Quantivirus as a liquid biopsy, to evaluate treatment response in cervical cancer.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States