Screening Women With Prior HPV for Anal Neoplasia

Recruiting now · Not applicable

Conditions studied: HPV-related Lower Genital Tract Neoplasias, HPV-related Anal Neoplasias, Early Stage Lower Genital Tract Cancers

In brief

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.

Key facts

Study ID

NCT05217940

Run by

Icahn School of Medicine at Mount Sinai

People needed

300

Starts

2022-03-02

Expected to finish

2027-01-01

Last updated by the study team

2025-08-22

Who can join

Age: 35 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• prior history or high resolution anoscopy

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
• Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
• University of Texas M D Anderson Cancer Center — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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