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

NCT07214584 | Recruiting DMC

• 1 other identifier: IRB202501136
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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 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. 1.Comparability of the Quantivirus HPV DNA/mRNA assay (DiaCarta, Inc) with the NavDx HPV DNA assay and,
2. 2.Feasibility of the Quantivirus technology for measuring treatment response within the first day to 2 weeks of radiation, surgery, or a new chemotherapy.

Conditions

Cervical Cancer; Human Papilloma Virus (HPV)

Keywords

HPV; HPV Positive Cervical Cancer; Cervical Cancer; Recurrent Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Feasibility of Circulating HPV DNA/mRNA Liquid Biopsy for Evaluating Treatment Response in Cervical Cancer

  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.

  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.

Eligibility Criteria

• Age: 18 Years - 89 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients with HPV associated cancers of the uterine cervix with active, evaluable/measurable disease.

You may qualify if:

• 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.

You may not qualify if:

• Unable to consent or refusal to sign a consent form
• Unable to comply with follow up scheduling.
• Diagnosed with a synchronous malignancy requiring cancer-directed therapy

Sponsors & Collaborators

• University of Florida: lead
• Florida Department of Health: collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Residual whole blood.

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Kari S Bastow, BS

CONTACT

352-265-8827; kari.bastow@ufhealth.org

Amy Carrao-Tackett, MPH

CONTACT

352-265-0680; amy.carrao-tackett@ufhealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2025
• First Posted: October 9, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 12, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)