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

Last updated: February 9, 2026
Sponsor: University of Florida
Overall Status: Active - Recruiting

Phase

N/A

Condition

Human Papilloma Virus (Hpv)

Dysfunctional Uterine Bleeding

Cervical Cancer

Treatment

N/A

Clinical Study ID

NCT07214584
IRB202501136
  • Ages 18-89
  • Female

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 18 years and older

  • HPV-associated squamous cell, adenocarcinoma, or adenosquamous cancers of theuterine cervix with evaluable disease

  • Diagnosed with American Joint Committee on Cancer (AJCC) stage I or higher, ormetastatic disease.

  • Presence of evaluable disease on pre-treatment standard of care imaging with plansto obtain serial post-treatment standard of care imaging

  • Agree to perform the required research-related blood tests and cervical mucoustesting.

Exclusion

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

Total Participants: 55
Study Start date:
December 15, 2025
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • University of Florida

    Gainesville 4156404, Florida 4155751 32610
    United States

    Active - Recruiting

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