NCT05217940 Screening Women With Prior HPV for Anal Neoplasia
| NCT ID | NCT05217940 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | HPV-related Lower Genital Tract Neoplasias |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2022-03-02 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2022-03-02 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Keith Sigel, MD, PhD, MPH
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT05217940 clinical trial?
This trial is open to female participants only, aged 35 Years or older, studying HPV-related Lower Genital Tract Neoplasias. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05217940 currently recruiting?
Yes, NCT05217940 is actively recruiting participants. Contact the research team at daniela.solis@mountsinai.org for enrollment information.
Where is the NCT05217940 trial being conducted?
This trial is being conducted at New York, United States, Charleston, United States, Houston, United States.
Who is sponsoring the NCT05217940 clinical trial?
NCT05217940 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Keith Sigel, MD, PhD, MPH at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 300 participants.