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