The Effectiveness of Screening Women With Lower Genital Tract Neoplasia or Cancers for Anal Cancer Precursors
Icahn School of Medicine at Mount Sinai
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 in…
Eligibility
- Age range
- 35+ years
- Sex
- Female
- Healthy volunteers
- No
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
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 SinaiNew York, New York
- Medical University of South CarolinaCharleston, South Carolina
- University of Texas M D Anderson Cancer CenterHouston, Texas