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RecruitingNCT07214584Updated Feb 12, 2026

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

An observational study in Cervical Cancer and Human Papilloma Virus (HPV), sponsored by University of Florida. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-02-12.

Sponsored by University of Florida · Observational

From the registry’s dates

  • Started Dec 2025; still recruiting 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
55
Ages
18 Years to 89 Years
Sex
Female
01

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.
02

Conditions studied

  • Cervical Cancer
  • Human Papilloma Virus (HPV)

Keywords

  • HPV
  • HPV Positive Cervical Cancer
  • Cervical Cancer
  • Recurrent Cervical Cancer
03

In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's planned enrollment of 55 is below the median of 220 across 419 observational studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
55 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

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.

    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.

07

Study locations

1 of 1 sites recruiting
  • University of Florida
    Gainesville, Florida 32610, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07214584
Lead sponsor
University of Florida
Collaborators
Florida Department of Health
Responsible party
Sponsor
First posted
Oct 9, 2025
Start date
Dec 15, 2025
Primary completion
Sep 30, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Feb 12, 2026

Study contacts

Kari S Bastow, BS
Contact
kari.bastow@ufhealth.org
352-265-8827
Amy Carrao-Tackett, MPH
Contact
amy.carrao-tackett@ufhealth.org
352-265-0680

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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