Application of Plasma Circulating HPV DNA Testing to Management of Cervical Intraepithelial Neoplasia

NCT04274465 | Completed DMC

• 1 other identifier: LCCC 1928
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Relationship between plasma cHPVDNA levels and presence of CIN 2-3 histopathology

  We will quantify cHPVDNA levels in blood plasma from patients with normal screening, CIN 1, and CIN 2-3 cervical disease prior to treatment.

  Baseline

Secondary Outcomes (1)

• Changes in cHPVDNA levels following excisional therapy for CIN 2-3 cervical disease.

  2-4 weeks post-excision

Study Arms (3)

Control

Negative high risk (HR)-HPV, cytology co-test

Diagnostic Test: digital PCR (dPCR) assay

CIN 1

Biopsy with low grade dysplasia

Diagnostic Test: digital PCR (dPCR) assay

CIN 2-3

Biopsy with high grade dysplasia

Diagnostic Test: digital PCR (dPCR) assay

Interventions

digital PCR (dPCR) assay DIAGNOSTIC_TEST

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

CIN 1; CIN 2-3; Control

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women ≥ 18 years old who are presenting to UNC Gynecology clinics with or without dysplasia and may or may not need colposcopy, biopsy, or lesion excisions.

You may qualify if:

• No history of previously treated cervical cancer
• Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee

You may not qualify if:

• Women who are pregnant or nursing

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

Tuvara Jenene King

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Blood and tissue collected will be retained for 15 years and will be tested for cHPVDNA.

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Shivani Sud, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 18, 2020
• Study Start: February 26, 2020
• Primary Completion: June 26, 2024
• Study Completion: July 15, 2024
• Last Updated: November 14, 2024

Record last verified: 2024-11

Locations

US (1)