Recruiting

Observational Study

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT05217940

Conditions

HPV-related Lower Genital Tract Neoplasias

HPV-related Anal Neoplasias

Early Stage Lower Genital Tract Cancers

Eligibility Criteria

Sex: Female

Age: 35+

Healthy Volunteers: Not accepted

Interventions

Diagnostic tests for anal cancer screening

Study Details

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.

Conditions

HPV-related Lower Genital Tract Neoplasias

HPV-related Anal Neoplasias

Early Stage Lower Genital Tract Cancers

Study ID

NCT05217940

Start date

Mar 2, 2022

Status verified date

Aug, 2025

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 35+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: Women With Prior HPV for Anal Neoplasia

Standard of care anal cancer screening with anal cytology, HPV testing and high resolution anoscopy.

Interventions

Diagnostic tests for anal cancer screening

The initial screening interventions will include the collection of (1) anal cytology; (2) self-collected HPV testing specimens (by subjects); (3) a clinician collected HPV specimen. A digital rectal exam will also be done on all patients.

Primary outcome measure

  • Sensitivity and specificity of anal cytology [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Daniela Solis

305-775-2140daniela.solis@mountsinai.org

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Nadia M Zubair, MPH

nadia.zubair@mountsinai.org

Principal Investigator:

Keith Sigel, MD PHD MPH

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Principal Investigator:

Ashish Deshmukh, PhD

University of Texas M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Elizabeth Chiao

EYChiao@mdanderson.org

Principal Investigator:

Elizabeth Chiao, MD

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Aug 22, 2025

Last verified

Aug, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-03. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2025-08-22.