Using Plasma Human Papillomavirus (HPV)-Related Deoxyribonucleic Acid (DNA) and Ribonucleic Acid (RNA) to Follow Response of Cervical Cancer to Surgery, Radiation, and Chemotherapy

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT07214584
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Study Details

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 polymerase chain reaction (PCR; NavDx) and the other on branched DNA (Quantivirus HPV \[DNA\]). A 9-month feasibility study will be performed to examine the side-by-side utility of both NavDx and Quantivirus HPV DNA assays in predicting cervical cancer treatment response. 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.

Key Dates

Start date
Dec 15, 2025
Status verified
Nov 2025
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
55 participants (estimated)

Primary Outcome Measure

Feasibility of Circulating HPV DNA/mRNA Liquid Biopsy for Evaluating Treatment Response in Cervical Cancer [ Time Frame: 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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32610
David Iglesias, MD
[email protected]
352-265-8200
Amy Carrao-Tackett
[email protected]
David Iglesias, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Gainesville, FL

By condition
Cervical cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
University of Florida· Gainesville, FL

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