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Search / Trial NCT05217940

Screening Women With Prior HPV for Anal Neoplasia

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Jan 31, 2022

Trial Information

Current as of July 05, 2025

Recruiting

Keywords

Anal Cancer Anal Precancerous Anal High Grade Intraepithelial Lesion Anal Cytology High Resolution Anoscopy Anal Human Papilloma Virus Testing

ClinConnect Summary

This clinical trial is looking at how to better screen for anal cancer precursors in women who have had certain types of HPV-related health issues in the past. The goal is to find effective ways to detect early signs of anal neoplasia, which means abnormal changes that could lead to cancer. The study is specifically for women who are not infected with HIV and have a history of significant HPV-related conditions in the lower genital tract, such as high-grade cervical lesions or previous non-metastatic cancers.

To be eligible for this trial, participants must be women aged 35 and older, with a documented history of high-grade HPV-related diseases. They should also be able to communicate in English or Spanish and have received care at either the Mount Sinai Health System or the Harris Health System in Houston. If you join the trial, you can expect to undergo screening methods aimed at early detection of potential anal cancer, contributing to better health outcomes for women in similar situations. This trial is currently recruiting participants, so there is an opportunity for eligible women to take part in this important research.

Gender

FEMALE

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

About Icahn School Of Medicine At Mount Sinai

The Icahn School of Medicine at Mount Sinai is a premier academic institution located in New York City, renowned for its commitment to advancing medical research, education, and patient care. As a leading sponsor of clinical trials, the institution leverages its state-of-the-art facilities and multidisciplinary expertise to drive innovative research initiatives aimed at improving health outcomes. With a focus on translational medicine, the Icahn School of Medicine collaborates with a diverse network of researchers, clinicians, and industry partners to explore novel therapies and interventions across a wide range of medical disciplines. Its rigorous scientific approach and dedication to ethical standards position it as a trusted leader in the clinical research landscape.

Locations

Charleston, South Carolina, United States

Houston, Texas, United States

New York, New York, United States

Houston, Texas, United States

Houston, Texas, United States

Patients applied

0 patients applied

Trial Officials

Keith Sigel, MD, PhD, MPH

Principal Investigator

Icahn School of Medicine at Mount Sinai

Elizabeth Chiao, MD

Principal Investigator

M.D. Anderson Cancer Center

Ashish Deshmukh, PhD

Principal Investigator

Medical University of South Carolina

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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