The Effectiveness of Screening Women With Lower Genital Tract Neoplasia or Cancers for Anal Cancer Precursors
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 300
- Locations
- 6
- Primary Endpoint
- Sensitivity and specificity of anal cytology
Study Overview
Brief 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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts 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
Outcomes
Primary Outcomes
Sensitivity and specificity of anal cytology
Time Frame: Baseline
Test sensitivity and specificity
Secondary Outcomes
- Concordance of self- and clinician-collected PCR testing(baseline)
- Prevalence of hrHPV types at baseline(Baseline)
- hrHPV with Cobas PCR testing (self-collected)(24 months)
- Incidence of aHSIL at follow-up(24 months)
- Proportion of subjects with new hrHPV infection(24 months)
- hrHPV with Cobas PCR testing (clinician-collected)(24 months)
- Screening Experience Survey(Baseline)
- Incidence of hrHPV, by type(24 months)
- Prevalence of aHSIL at baseline(Baseline)
Investigators
Keith M Sigel
Associate Professor
Icahn School of Medicine at Mount Sinai