Screening Women With Prior HPV for Anal Neoplasia
Part of paid clinical trials in New York, New York.
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Study ID
- NCT05217940
- Status
- Recruiting
Conditions
- Early Stage Lower Genital Tract Cancers
- HPV-related Anal Neoplasias
- HPV-related Lower Genital Tract Neoplasias
Eligibility Criteria
- Sex
- FEMALE
- Age
- 35 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Diagnostic tests for anal cancer screening — DIAGNOSTIC_TESTThe 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.
Study Details
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.
Key Dates
- Start date
- Mar 2, 2022
- Status verified
- Aug 2025
- Primary completion
- Jan 31, 2027
- Completion
- Jan 31, 2027
Study Design
- Enrollment
- 300 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- SCREENING
Arms
- Experimental: Women With Prior HPV for Anal NeoplasiaStandard of care anal cancer screening with anal cytology, HPV testing and high resolution anoscopy.
Primary Outcome Measure
Sensitivity and specificity of anal cytology [ Time Frame: Baseline ]
Central Contacts
- Daniela Solis305-775-2140
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | Nadia M Zubair, MPH Keith Sigel, MD PHD MPH (PRINCIPAL_INVESTIGATOR) |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | Ashish Deshmukh, PhD (PRINCIPAL_INVESTIGATOR) |
| University of Texas M D Anderson Cancer Center | Houston | Texas | 77030 | Elizabeth Chiao Elizabeth Chiao, MD (PRINCIPAL_INVESTIGATOR) |