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NCT05217940 | RECRUITING | HPV-related Lower Genital Tract Neoplasias

Screening Women With Prior HPV for Anal Neoplasia
Sponsor:

Icahn School of Medicine at Mount Sinai

Information provided by (Responsible Party):

Keith M Sigel

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.

Condition or disease

HPV-related Lower Genital Tract Neoplasias

HPV-related Anal Neoplasias

Early Stage Lower Genital Tract Cancers

Intervention/treatment

Diagnostic tests for anal cancer screening

Phase

NA

Detailed Description:

This single arm trial will enroll 300 HIV uninfected women with a history of genital neoplasia (ie., cervical intraepithelial neoplasia grade 2-3, vaginal intraepithelial neoplasia grade 2-3 or vulvar intraepithelial neoplasia grade 2-3) or early stage cervical or vulvar cancer to evaluate the test characteristics of anal cancer screening tests (cytology, HPV testing and high resolution anoscopy) and determine the prevalence and incidence of anal high-grade squamous intraepithelial lesions in this population. Participants will undergo evaluation at baseline and then at 12 and 24 months. The investigators will also measure the acceptability of anal cancer screening in this previously unstudied group. The trial is expected to run from 2021-2027.

Study Type : INTERVENTIONAL
Estimated Enrollment : 300 participants
Masking : NONE
Primary Purpose : SCREENING
Official Title : The Effectiveness of Screening Women With Lower Genital Tract Neoplasia or Cancers for Anal Cancer Precursors
Actual Study Start Date : 2022-03-02
Estimated Primary Completion Date : 2027-01
Estimated Study Completion Date : 2027-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 35 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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
Screening Women With Prior HPV for Anal Neoplasia

Location Details

NCT05217940

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New York

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

NOT YET RECRUITING

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

RECRUITING

United States, Texas

University of Texas M D Anderson Cancer Center

Houston, Texas, United States, 77030