Application of Plasma Circulating HPV DNA Testing to Management of Cervical Intraepithelial Neoplasia
NCT04274465 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 145
Last updated 2024-11-14
Summary
The purpose of this study is to see if circulating HPV DNA (cHPVDNA) can be used as a noninvasive biomarker for cervical intraepithelial neoplasia (CIN) 2-3 in hopes of reducing procedures and costs for patients, as well as personalize their treatment plan.
Conditions
- Cervix Lesion
- Cervical Cancer
Interventions
- DIAGNOSTIC_TEST
-
digital PCR (dPCR) assay
It is a highly sensitive and specific droplet digital PCR assay for absolute quantification of circulating tumor HPV DNA for the most prevalent HPV types that will determine if a woman has cHPVDNA
Sponsors & Collaborators
-
UNC Lineberger Comprehensive Cancer Center
lead OTHER
Principal Investigators
-
Shivani Sud, MD · University of North Carolina, Chapel Hill
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-02-26
- Primary Completion
- 2024-06-26
- Completion
- 2024-07-15
Countries
- United States
Study Locations
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