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

UNC Lineberger Comprehensive Cancer Center

Status: Completed

Conditions: Cervical Cancer; Cervix Lesion

Treatments: Diagnostic Test: digital PCR (dPCR) assay

Study type: Observational

Funder types: Other

Identifiers

NCT04274465

LCCC 1928

Details and patient eligibility

About

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.

Full 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.

Enrollment: 145 patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

145 participants in 3 patient groups

Control

Description:

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

Treatment:

Diagnostic Test: digital PCR (dPCR) assay

CIN 1

Description:

Biopsy with low grade dysplasia

Treatment:

Diagnostic Test: digital PCR (dPCR) assay

CIN 2-3

Description:

Biopsy with high grade dysplasia

Treatment:

Diagnostic Test: digital PCR (dPCR) assay