Actively Recruiting
Using Plasma Human Papillomavirus (HPV)-Related Deoxyribonucleic Acid (DNA) and Ribonucleic Acid (RNA) to Follow Response of Cervical Cancer to Surgery, Radiation, and Chemotherapy
Led by University of Florida · Updated on 2026-02-12
55
Participants Needed
1
Research Sites
54 weeks
Total Duration
On this page
Sponsors
U
University of Florida
Lead Sponsor
F
Florida Department of Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Using Plasma Human Papillomavirus (HPV)-Related Deoxyribonucleic Acid (DNA) and Ribonucleic Acid (RNA) to Follow Response of Cervical Cancer to Surgery, Radiation, and Chemotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
Research Team
K
Kari S Bastow, BS
CONTACT
A
Amy Carrao-Tackett, MPH
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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