Screening Women With Prior HPV for Anal Neoplasia
Recruiting · NCT05217940 · Interventional (participants receive a specific treatment) · Lead sponsor: Icahn School of Medicine at Mount Sinai
View the official record on ClinicalTrials.gov →Interventions studied
Diagnostic tests for anal cancer screening
What this trial is about
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.
Who can take part
Age range
35 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
3 locations listed across 3 US states.
- Icahn School of Medicine at Mount Sinai - New York, New York, United States
- Medical University of South Carolina - Charleston, South Carolina, United States
- University of Texas M D Anderson Cancer Center - Houston, Texas, United States