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

No results posted yet for this study

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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04274465 on ClinicalTrials.gov