RecruitingNot ApplicableNCT05217940

Screening Women With Prior HPV for Anal Neoplasia

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


Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

300 participants

Start Date

Mar 2, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 35 Years

Plain Language Summary

Simplified for easier understanding

This study is screening women who have had high-grade genital HPV-related precancerous conditions or cancers for anal cancer precursors (called anal neoplasia). HPV infections that cause cervical or vulvar disease can also cause similar problems in the anal area, but this is often overlooked in clinical care. **You may be eligible if...** - You are a woman aged 35 or older - You have a documented history of high-grade cervical, vulvar, or vaginal precancerous lesions (CIN2+, VIN2+, VAIN2+) or non-metastatic cervical, vaginal, or vulvar cancer - You have tested negative for HIV - You are a patient at Mount Sinai Health System (New York) or Harris Health System (Houston) - You speak English or Spanish **You may NOT be eligible if...** - You have previously had a high-resolution anoscopy (a procedure to examine the anal canal) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTDiagnostic 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.


Locations(3)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Medical University of South Carolina

Charleston, South Carolina, United States

University of Texas M D Anderson Cancer Center

Houston, Texas, United States

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NCT05217940