Using Plasma Human Papillomavirus (HPV)-Related Deoxyribonucleic Acid (DNA) and Ribonucleic Acid (RNA) to Follow Response of Cervical Cancer to Surgery, Radiation, and Chemotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cervical Cancer, Human Papilloma Virus (HPV). Basic parameters: 18 years — 89 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- University of Florida — Gainesville
Identifiers
NCT: NCT07214584 · IRB202501136