Screening women with a history of HPV for anal cancer precursors
Official title: The Effectiveness of Screening Women With Lower Genital Tract Neoplasia or Cancers for Anal Cancer Precursors
Run by Icahn School of Medicine at Mount Sinai · NCT05217940 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 35 Years and up |
| Sex | Women only |
| Enrollment | 300 (estimated) |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 3 sites (New York, New York and 2 other locations) |
| Status | Recruiting |
| Started | March 2, 2022 |
| Main results expected | January 2027 |
| Study ends | January 2027 |
| Registry record updated | October 13, 2026 |
| Trial ID | NCT05217940 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with a prior history of high-resolution anoscopy will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is novel for this specific population, similar studies have shown success in screening for anal cancer in other high-risk groups.
Who can join: the full rules
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 it's running
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Blood ctDNA testing to guide follow-up and treatment for HPV-related cervical and anal canal cancers.
This study will test whether regular blood tests for HPV ctDNA can guide follow-up and whether giving pembrolizumab after radiotherapy helps people with HPV-related cervical or anal canal cancer who still have positive ctDNA.
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Screening methods for high-risk anal cancer patients
This study is testing new ways to screen for early signs of anal cancer in high-risk people, especially those living with HIV, to help improve their health outcomes.
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E7 T-cell therapy for advanced HPV-related cancers
This study is testing a new treatment using specially modified immune cells to see if it can help people with advanced cancers linked to HPV feel better and live longer.
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Finding HPV DNA in the blood of people with anal or cervical cancer.
This study will test whether a blood test can find HPV DNA in people with HPV-related anal or cervical cancer before, during, and after radiation treatment.
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Screening for anal cancer in women with vulvar lesions
This study is testing if screening for anal cancer with Pap smears can help women over 40 who have vulvar lesions catch any problems early and improve their health.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.