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
Inclusion Criteria5
- 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 Criteria1
- • prior history or high resolution anoscopy
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)
View Full Details on ClinicalTrials.gov
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NCT05217940