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NCT05217940NARecruiting

Screening Women With Prior HPV for Anal Neoplasia

Icahn School of Medicine at Mount Sinai

Start Date

3/2/2022

Completion Date

1/1/2027

Summary

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.

Detailed Description

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.

Eligibility Criteria

Age Range: 35 years to No maximum

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

Interventions

DIAGNOSTIC_TEST

Diagnostic tests for anal cancer screening

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Conditions

HPV-related Lower Genital Tract NeoplasiasHPV-related Anal NeoplasiasEarly Stage Lower Genital Tract Cancers

Locations

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

University of Texas M D Anderson Cancer Center

Houston, Texas 77030

United States