Screening Women With Prior HPV for Anal Neoplasia (SWAN)

  • STATUS
    Recruiting
  • End date
    Jan 10, 2027
  • participants needed
    300
  • sponsor
    Icahn School of Medicine at Mount Sinai
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Updated on 10 February 2026
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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.

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.

Details
Condition HPV-related Lower Genital Tract Neoplasias, HPV-related Anal Neoplasias, Early Stage Lower Genital Tract Cancers
Age 35years or above
Clinical Study IdentifierNCT05217940
SponsorIcahn School of Medicine at Mount Sinai
Last Modified on10 February 2026

Eligibility

 Yes No Not Sure

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
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