RECRUITING

Screening Women With Prior HPV for Anal Neoplasia

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Conditions

HPV-related Lower Genital Tract NeoplasiasHPV-related Anal NeoplasiasEarly Stage Lower Genital Tract Cancersanal canceranal precancerousanal high grade intraepithelial lesionanal cytologyhigh resolution anoscopyanal human papilloma virus testing

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

The Effectiveness of Screening Women With Lower Genital Tract Neoplasia or Cancers for Anal Cancer Precursors

Quick Facts

Study Start:2022-03-02
Study Completion:2026-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05217940

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:35 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * Documented HIV seronegativity
  3. * Aged 35 years and older
  4. * Seen in the Mount Sinai Health System (MSHS) or the Harris Health System (HHS) in Houston
  5. * English or Spanish speaking
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Daniela Solis
CONTACT
305-775-2140
daniela.solis@mountsinai.org

Principal Investigator

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

Study Locations (Sites)

Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
University of Texas M D Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • 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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-02
Study Completion Date2026-11

Study Record Updates

Study Start Date2022-03-02
Study Completion Date2026-11

Terms related to this study

Keywords Provided by Researchers

  • anal cancer
  • anal precancerous
  • anal high grade intraepithelial lesion
  • anal cytology
  • high resolution anoscopy
  • anal human papilloma virus testing

Additional Relevant MeSH Terms

  • HPV-related Lower Genital Tract Neoplasias
  • HPV-related Anal Neoplasias
  • Early Stage Lower Genital Tract Cancers