Clinical trial NCT04274465: Application of Plasma Circulating HPV DNA Testing to Management of Cervical Intraepithelial Neoplasia
Official title: Application of Plasma Circulating Human Papillomavirus (HPV) DNA Testing to Management of Cervical Intraepithelial Neoplasia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervix Lesion
Cervical Cancer
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2020-02-18
Enrollment: 145
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Relationship between plasma cHPVDNA levels and presence of CIN 2-3 histopathology
timeFrame: Baseline
Secondary outcomes:
measure: Changes in cHPVDNA levels following excisional therapy for CIN 2-3 cervical disease.
timeFrame: 2-4 weeks post-excision
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Tuvara Jenene King
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Shivani Sud, MD
role: PRINCIPAL_INVESTIGATOR
References: