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NCT Number: NCT05217940

Screening Women With Prior HPV for Anal Neoplasia

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.

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Key information

Conditions

HPV-related Lower Genital Tract Neoplasias Anus Diseases Anus Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Early Stage Lower Genital Tract Cancers Gastrointestinal Diseases Gastrointestinal Neoplasms HPV-related Anal Neoplasias Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

35 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostic tests for anal cancer screening

Diagnostic Test

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 outcomes

  1. Sensitivity and specificity of anal cytology

    Time frame: Baseline

    Test sensitivity and specificity

Secondary outcomes

  1. Concordance of self- and clinician-collected PCR testing

    Time frame: baseline

    Proportionate concordance of high-risk HPV testing

  2. Prevalence of hrHPV types at baseline

    Time frame: Baseline

    Proportion of subjects with high-risk HPV and subtype proportions

  3. hrHPV with Cobas PCR testing (self-collected)

    Time frame: Baseline

    Presence of high-risk HPV subtype

  4. hrHPV with Cobas PCR testing (self-collected)

    Time frame: 12 months

    Presence of high-risk HPV subtype

  5. hrHPV with Cobas PCR testing (self-collected)

    Time frame: 24 months

    Presence of high-risk HPV subtype

  6. hrHPV with Cobas PCR testing (clinician-collected)

    Time frame: Baseline

    Presence of high-risk HPV subtype

  7. hrHPV with Cobas PCR testing (clinician-collected)

    Time frame: 12 months

    Presence of high-risk HPV subtype

  8. hrHPV with Cobas PCR testing (clinician-collected)

    Time frame: 24 months

    Presence of high-risk HPV subtype

  9. Prevalence of aHSIL at baseline

    Time frame: Baseline

    Proportion of subjects with aHSIL

  10. Incidence of aHSIL at follow-up

    Time frame: 24 months

    Proportion of subjects with new aHSIL during follow-up period

  11. Screening Experience Survey

    Time frame: Baseline

    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.

  12. Incidence of hrHPV, by type

    Time frame: 12 months

    Proportion of subjects with new hrHPV infection

  13. Incidence of hrHPV, by type

    Time frame: 24 months

    Proportion of subjects with new hrHPV infection

  14. Proportion of subjects with new hrHPV infection

    Time frame: 12 months

    Proportion of subjects with prevalent hrHPV without measurable hrHPV at follow-up

  15. Proportion of subjects with new hrHPV infection

    Time frame: 24 months

    Proportion of subjects with prevalent hrHPV without measurable hrHPV at follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Daniela Solis

CONTACT

[email protected]

305-775-2140

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • M.D. Anderson Cancer Center
  • Medical University of South Carolina

Registry information

Official study title

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

Acronym: SWAN

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Feb 1, 2022
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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