Screening Women With Prior HPV for Anal Neoplasia (SWAN)

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

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.

Study Overview

• Status: Recruiting
• Conditions: HPV-related Lower Genital Tract Neoplasias; HPV-related Anal Neoplasias; Early Stage Lower Genital Tract Cancers
• Intervention / Treatment: Diagnostic test: Diagnostic tests for anal cancer screening

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
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniela Solis; Phone Number: 305-775-2140; Email: daniela.solis@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • ICAHN School of Medicine at Mount Sinai
      • Contact: Nadia M Zubair, MPH; Email: nadia.zubair@mountsinai.org
      • Principal Investigator: Keith Sigel, MD PHD MPH
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
      • Principal Investigator: Ashish Deshmukh, PhD
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • University of Texas M D Anderson Cancer Center
      • Contact: Elizabeth Chiao; Email: EYChiao@mdanderson.org
      • Principal Investigator: Elizabeth Chiao, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Women With Prior HPV for Anal Neoplasia; Standard of care anal cancer screening with anal cytology, HPV testing and high resolution anoscopy.	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity of anal cytology	Test sensitivity and specificity	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concordance of self- and clinician-collected PCR testing	Proportionate concordance of high-risk HPV testing	baseline
Prevalence of hrHPV types at baseline	Proportion of subjects with high-risk HPV and subtype proportions	Baseline
hrHPV with Cobas PCR testing (self-collected)	Presence of high-risk HPV subtype	Baseline
hrHPV with Cobas PCR testing (self-collected)	Presence of high-risk HPV subtype	12 months
hrHPV with Cobas PCR testing (self-collected)	Presence of high-risk HPV subtype	24 months
hrHPV with Cobas PCR testing (clinician-collected)	Presence of high-risk HPV subtype	Baseline
hrHPV with Cobas PCR testing (clinician-collected)	Presence of high-risk HPV subtype	12 months
hrHPV with Cobas PCR testing (clinician-collected)	Presence of high-risk HPV subtype	24 months
Prevalence of aHSIL at baseline	Proportion of subjects with aHSIL	Baseline
Incidence of aHSIL at follow-up	Proportion of subjects with new aHSIL during follow-up period	24 months
Screening Experience Survey	Survey measures anal cancer screening test acceptability. Each item is scored 0-3, with higher score indicting more acceptability. 0-3. There is no total scale. Each question is scored separately and the overall results are used qualitatively.	Baseline
Incidence of hrHPV, by type	Proportion of subjects with new hrHPV infection	12 months
Incidence of hrHPV, by type	Proportion of subjects with new hrHPV infection	24 months
Proportion of subjects with new hrHPV infection	Proportion of subjects with prevalent hrHPV without measurable hrHPV at follow-up	12 months
Proportion of subjects with new hrHPV infection	Proportion of subjects with prevalent hrHPV without measurable hrHPV at follow-up	24 months

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Medical University of South Carolina; M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Keith Sigel, MD, PhD, MPH, ICAHN School of Medicine at Mount Sinai; Principal Investigator: Elizabeth Chiao, MD, M.D. Anderson Cancer Center; Principal Investigator: Ashish Deshmukh, PhD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: January 14, 2022
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 21, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: anal cancer; anal precancerous; anal high grade intraepithelial lesion; anal cytology; high resolution anoscopy; anal human papilloma virus testing
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: GCO 20-0309

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: Beginning 3 months and ending 5 years following article publication.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal. Any purpose. Email principal investigator: keith.sigel@mssm.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No