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

Cervical Cancer Clinical Trial

Official title:

Application of Plasma Circulating Human Papillomavirus (HPV) DNA Testing to Management of Cervical Intraepithelial Neoplasia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04274465
• Other study ID #: LCCC 1928
• Status: Recruiting
• Start date: February 26, 2020
• Est. completion date: November 2025

Study information

• Verified date: September 2023
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: Tuvara J King
• Phone: 984-974-8441
• Email: tjking[@]med.unc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 85
• Est. completion date: November 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Cervix Lesion
• Uterine Cervical Dysplasia

Intervention

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

Locations

Country	Name	City	State
United States	Tuvara Jenene King	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

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