RecruitingNot Applicable

Screening Women With Prior HPV for Anal Neoplasia

United States300 participantsStarted 2022-03-02

Plain-language 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.

Who can participate

Age range35 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: • prior history or high resolution anoscopy

What they're measuring

Sensitivity and specificity of anal cytology

Timeframe: Baseline

Trial details

NCT IDNCT05217940

SponsorIcahn School of Medicine at Mount Sinai

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01

Contact for this trial

Daniela Solis

305-775-2140 daniela.solis@mountsinai.org

View on ClinicalTrials.gov More HPV-related Lower Genital Tract Neoplasias trials