Screening Women With Prior HPV for Anal Neoplasia

Icahn School of Medicine at Mount Sinai300 enrolled

Overview

The goal of this single arm trial is to prospectively evaluate screening methods for anal cancer precursors in HIV uninfected women with a history of lower genital tract neoplasias and cancers.

This single arm trial will enroll 300 HIV uninfected women with a history of genital neoplasia (ie., cervical intraepithelial neoplasia grade 2-3, vaginal intraepithelial neoplasia grade 2-3 or vulvar intraepithelial neoplasia grade 2-3) or early stage cervical or vulvar cancer to evaluate the test characteristics of anal cancer screening tests (cytology, HPV testing and high resolution anoscopy) and determine the prevalence and incidence of anal high-grade squamous intraepithelial lesions in this population. Participants will undergo evaluation at baseline and then at 12 and 24 months. The investigators will also measure the acceptability of anal cancer screening in this previously unstudied group. The trial is expected to run from 2021-2027.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

300

Conditions

Interventions

Diagnostic tests for anal cancer screeningDIAGNOSTIC_TEST

The initial screening interventions will include the collection of (1) anal cytology; (2) self-collected HPV testing specimens (by subjects); (3) a clinician collected HPV specimen. A digital rectal exam will also be done on all patients.

Eligibility

Sex: FEMALEMin age: 35 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women with a history of pathologically proven high-grade genital HPV-associated neoplastic disease (cervical intraepithelial neoplasia 2+, vulvar intraepithelial neoplasia 2+, or vaginal intraepithelial neoplasia 2+, or history of non-metastatic cervical, vaginal or vulvar cancer) * Documented HIV seronegativity * Aged 35 years and older * Seen in the Mount Sinai Health System (MSHS) or the Harris Health System (HHS) in Houston * English or Spanish speaking Exclusion Criteria: • prior history or high resolution anoscopy

Locations (3)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, United States

RECRUITING

University of Texas M D Anderson Cancer Center

Houston, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

Sensitivity and specificity of anal cytology

Test sensitivity and specificity

Time frame: Baseline

Secondary Outcomes

Concordance of self- and clinician-collected PCR testing

Proportionate concordance of high-risk HPV testing

Time frame: baseline

Prevalence of hrHPV types at baseline

Proportion of subjects with high-risk HPV and subtype proportions

Time frame: Baseline

hrHPV with Cobas PCR testing (self-collected)