Screening Women With Prior HPV for Anal Neoplasia
- Conditions
- Early Stage Lower Genital Tract CancersHPV-related Anal NeoplasiasHPV-related Lower Genital Tract Neoplasias
- Interventions
- Diagnostic Test: Diagnostic tests for anal cancer screening
- Registration Number
- NCT05217940
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 300
- 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
• prior history or high resolution anoscopy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Women With Prior HPV for Anal Neoplasia Diagnostic tests for anal cancer screening Standard of care anal cancer screening with anal cytology, HPV testing and high resolution anoscopy.
- Primary Outcome Measures
Name Time Method Sensitivity and specificity of anal cytology Baseline Test sensitivity and specificity
- Secondary Outcome Measures
Name Time Method Concordance of self- and clinician-collected PCR testing baseline Proportionate concordance of high-risk HPV testing
Prevalence of hrHPV types at baseline Baseline Proportion of subjects with high-risk HPV and subtype proportions
hrHPV with Cobas PCR testing (self-collected) 24 months Presence of high-risk HPV subtype
Incidence of aHSIL at follow-up 24 months Proportion of subjects with new aHSIL during follow-up period
Proportion of subjects with new hrHPV infection 24 months Proportion of subjects with prevalent hrHPV without measurable hrHPV at follow-up
hrHPV with Cobas PCR testing (clinician-collected) 24 months Presence of high-risk HPV subtype
Screening Experience Survey Baseline Survey measures anal cancer screening test acceptability. Each item is scored 0-3, with higher score indicting more acceptability. 0-3. There is no total scale. Each question is scored separately and the overall results are used qualitatively.
Incidence of hrHPV, by type 24 months Proportion of subjects with new hrHPV infection
Prevalence of aHSIL at baseline Baseline Proportion of subjects with aHSIL
Trial Locations
- Locations (3)
University of Texas M D Anderson Cancer Center
🇺🇸Houston, Texas, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States