Actively Recruiting

Phase Not Applicable
Age: 35Years +
FEMALE
NCT05217940

Screening Women With Prior HPV for Anal Neoplasia

Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-08-22

300

Participants Needed

3

Research Sites

252 weeks

Total Duration

On this page

Sponsors

I

Icahn School of Medicine at Mount Sinai

Lead Sponsor

M

M.D. Anderson Cancer Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Screening Women With Prior HPV for Anal Neoplasia

Who Can Participate

Age: 35Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Prior history of high resolution anoscopy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Actively Recruiting

2

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Actively Recruiting

3

University of Texas M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

D

Daniela Solis

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SCREENING

Number of Arms

1

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