Status:
RECRUITING
Screening Women With Prior HPV for Anal Neoplasia
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
M.D. Anderson Cancer Center
Medical University of South Carolina
Conditions:
HPV-related Lower Genital Tract Neoplasias
HPV-related Anal Neoplasias
Eligibility:
FEMALE
35+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- • prior history or high resolution anoscopy
Key Trial Info
Start Date :
March 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05217940
Start Date
March 2 2022
End Date
January 1 2027
Last Update
August 22 2025
Active Locations (3)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
2
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
3
University of Texas M D Anderson Cancer Center
Houston, Texas, United States, 77030