Recruiting

NavDx & Quantivirus

Sponsor:

University of Florida

Code:

NCT07214584

Conditions

Cervical Cancer

Human Papilloma Virus (HPV)

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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. 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.

Conditions

Cervical Cancer

Human Papilloma Virus (HPV)

Study ID

NCT07214584

Start date

Dec 15, 2025

Status verified date

Nov, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not 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

Study Design

Enrollment

55 participants

Anticipated

Interventions and Outcome Measures

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 and Locations

Central contacts

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Principal Investigator:

David Iglesias, MD

More Information

Sponsor

University of Florida

Last update posted

Feb 12, 2026

Last verified

Nov, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-02-12.