Trials / Recruiting

RecruitingNCT05217940

Screening Women With Prior HPV for Anal Neoplasia

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

Status: Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 300 (estimated)

Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
Sex: Female
Age: 35 Years
Healthy volunteers: Not accepted

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.

Conditions

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Diagnostic tests for anal cancer screening	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.

Timeline

Start date: 2022-03-02
Primary completion: 2027-01-01
Completion: 2027-01-01
First posted: 2022-02-01
Last updated: 2025-08-22

Locations

3 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT05217940. Inclusion in this directory is not an endorsement.