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 Title of Study: “Application of Plasma Circulating Human Papillomavirus (HPV) DNA Testing to Management of Cervical Intraepithelial Neoplasia”
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: May 2021
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.
- 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
Arms, Groups and Cohorts
- Negative high risk (HR)-HPV, cytology co-test
- CIN 1
- Biopsy with low grade dysplasia
- CIN 2-3
- Biopsy with high grade dysplasia
Clinical Trial Outcome Measures
- Relationship between plasma cHPVDNA levels and presence of CIN 2-3 histopathology
- Time Frame: 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.
- Changes in cHPVDNA levels following excisional therapy for CIN 2-3 cervical disease.
- Time Frame: 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.
Participating in This Clinical Trial
- 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
Gender Eligibility: Female
Minimum Age: 18 Years
Maximum Age: 99 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Provider of Information About this Clinical Study
- Overall Official(s)
- Ashley Weiner, MD, PhD, Principal Investigator, University of North Carolina, Chapel Hill
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