Using Plasma Human Papillomavirus (HPV)-Related Deoxyribonucleic Acid (DNA) and Ribonucleic Acid (RNA) to Follow Response of Cervical Cancer to Surgery, Radiation, and Chemotherapy
NCT ID: NCT07214584
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
55 participants
OBSERVATIONAL
2025-12-15
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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.
* Unable to comply with follow up scheduling.
* Diagnosed with a synchronous malignancy requiring cancer-directed therapy
Exclusion Criteria
18 Years
89 Years
FEMALE
No
Sponsors
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Florida Department of Health
OTHER_GOV
University of Florida
OTHER
Responsible Party
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Locations
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University of Florida
Gainesville, Florida, United States
Countries
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Central Contacts
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Other Identifiers
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IRB202501136
Identifier Type: -
Identifier Source: org_study_id
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