Spots Global Cancer Trial Database for Screening Women With Prior HPV for Anal Neoplasia

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Trial Identification

Brief Title: Screening Women With Prior HPV for Anal Neoplasia

Official Title: The Effectiveness of Screening Women With Lower Genital Tract Neoplasia or Cancers for Anal Cancer Precursors

Study ID: NCT05217940

Conditions

HPV-related Anal Neoplasias

Early Stage Lower Genital Tract Cancers

Interventions

Diagnostic tests for anal cancer screening

Study Description

Brief 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 2021-2025.