Screening women with a history of HPV for anal cancer precursors
The Effectiveness of Screening Women With Lower Genital Tract Neoplasia or Cancers for Anal Cancer Precursors
This study is testing different screening methods for anal cancer precursors in women who have had HPV and certain other cancers to see which ones work best.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 35 Years and up |
| Sex | Female |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 3 sites (New York, New York and 2 other locations) |
| Trial ID | NCT05217940 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate screening methods for anal cancer precursors in HIV uninfected women who have a history of lower genital tract neoplasias and cancers. It will enroll 300 participants to assess the effectiveness of various screening tests, including cytology, HPV testing, and high-resolution anoscopy. Participants will be evaluated at baseline and again at 12 and 24 months to determine the prevalence of anal high-grade squamous intraepithelial lesions and the acceptability of these screening methods. The study is expected to run from 2021 to 2027.
Who should consider this trial
Good fit: Ideal candidates for this study are HIV uninfected women aged 35 and older with a history of high-grade genital HPV-associated neoplastic disease.
Not a fit: Patients with a prior history of high-resolution anoscopy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved screening methods for anal cancer precursors, potentially reducing the incidence of anal cancer in at-risk populations.
How similar studies have performed: While this approach is novel for this specific population, similar studies have shown success in screening for anal cancer in other high-risk groups.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New York, New York and 2 other locations
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
- Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)
- University of Texas M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Keith Sigel, MD, PhD, MPH — Icahn School of Medicine at Mount Sinai
- Study coordinator: Daniela Solis
- Email: daniela.solis@mountsinai.org
- Phone: 305-775-2140
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.