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

RECRUITINGSponsored by University of Florida
Actively Recruiting
SponsorUniversity of Florida
Started2025-12-15
Est. completion2026-09-30
Eligibility
Age18 Years – 89 Years
SexFEMALE
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT07214584

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 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.

Eligibility

Age: 18 Years – 89 YearsSex: FEMALEHealthy volunteers accepted
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

Conditions3

CancerCervical CancerHuman Papilloma Virus (HPV)

Locations1 site

University of Florida
Gainesville, Florida, 32610
David Iglesias, MD352-265-8200iglesiad@ufl.edu

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