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

Completed

• Conditions: Cervix Lesion; Cervical Cancer
• Interventions: Diagnostic Test: digital PCR (dPCR) assay

• Registration Number: NCT04274465
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

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.

Detailed Description

cHPVDNA is detectable in plasma of patients with invasive disease and CIN 1-3, and with the development of a highly sensitive and specific droplet digital Polymerase Chain Reaction (PCR) assay, it is hoped to be identified more prevalently and thus can improve risk stratification and help produce personalized treatment decisions and may be more cost-efficient. Plasma samples and cervical swabs will be collected from patients in University of North Carolina (UNC) Gynecology clinics, and some patients will also provide a urine sample. Those receiving biopsies or colposcopies and will come back to clinic 2-4 weeks post-excision for collection of another blood specimen. Using plasma samples and pathology results, we will characterize the relationship between plasma cHPVDNA levels and 1) CIN 1 versus CIN 2-3 pathology 2) CIN 2-3 pre-excision and 2-4 weeks post-excision. We will accrue three cohorts of 25, 30, 30 patients corresponding to 1) Control 2) CIN 1 3) CIN 2-3. The control cohort will establish background signal in the assay. We will compare the proportion of detectable cHPVDNA levels between CIN 1 and CIN 2-3 cohorts using Fisher's exact test with 80% power, significance level of 10%. Paired t-test will be used to compare pre- and post-excision cHPVDNA levels.

Study Timeline

• Study First Submitted: 2020-02-14
• Study First Submitted QC: 2020-02-14
• Study First Posted: 2020-02-18
• Study Start: 2020-02-26
• Primary Completion: 2024-06-26
• Study Completion: 2024-07-15
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 145

Inclusion Criteria

• 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

Exclusion Criteria

• Women who are pregnant or nursing

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	digital PCR (dPCR) assay	Negative high risk (HR)-HPV, cytology co-test
CIN 1	digital PCR (dPCR) assay	Biopsy with low grade dysplasia
CIN 2-3	digital PCR (dPCR) assay	Biopsy with high grade dysplasia

Primary Outcome Measures

Name	Time	Method
Relationship between plasma cHPVDNA levels and presence of CIN 2-3 histopathology	Baseline	We will quantify cHPVDNA levels in blood plasma from patients with normal screening, CIN 1, and CIN 2-3 cervical disease prior to treatment.

Secondary Outcome Measures

Name	Time	Method
Changes in cHPVDNA levels following excisional therapy for CIN 2-3 cervical disease.	2-4 weeks post-excision	For patients who undergo excisional therapy, we will collect bio-specimens and quantify cHPVDNA levels in plasma during their post-procedure visit.

Trial Locations

Locations (1)

Tuvara Jenene King; 🇺🇸 Chapel Hill, North Carolina, United States