Clinical trial Recruiting at 1 site Interventional Ages 40 and up Women only

Screening for anal cancer in women with vulvar lesions

Official title: Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer.

Run by Sunnybrook Health Sciences Centre · NCT03061435 · Data updated 2026-11-12

This study is testing if screening for anal cancer with Pap smears can help women over 40 who have vulvar lesions catch any problems early and improve their health.

More Cervical Cancer trials

Quick facts

Study typeInterventional
Ages40 Years and up
SexWomen only
Enrollment110 (estimated)
SponsorSunnybrook Health Sciences Centre
Academic / other
Locations1 site (Toronto, Ontario)
StatusRecruiting
StartedFebruary 1, 2021
Main results expectedAugust 1, 2025
Study endsJanuary 1, 2026
Registry record updatedMay 16, 2025
Trial IDNCT03061435 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are women aged 40 and older with a previous diagnosis of high-grade vulvar dysplasia or vulvar cancer.

Probably not a fit

Patients who have a history of other cancers (except for basal cell carcinoma), are HIV positive, or are on immunosuppressant medications may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to screen women over the age of 40 who have high-grade vulvar dysplasia or vulvar cancer for anal cancer, which currently lacks established screening protocols. Participants will undergo anal Pap smears and, if abnormalities are detected, high-resolution anoscopy for further evaluation and treatment. The study is based on the premise that women with gynecological lesions are at increased risk for anal lesions and cancer. By identifying and treating anal cancer early, the study seeks to improve patient outcomes.

Why it matters

Potential benefit: If successful, this study could lead to early detection and treatment of anal cancer in women at high risk, potentially improving survival rates.

How similar studies have gone: While screening for anal cancer in this specific population is novel, previous studies have indicated a higher risk of anal lesions in women with gynecological cancers, suggesting potential for success.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Women age ≥ 40
* Previous diagnosis of VIN 2/3 or vulvar

Exclusion Criteria:

* Women with a previous diagnosis of cancer aside from basal cell carcinoma of the skin, cervical cancer, or vulvar cancer
* Women who are HIV positive
* Women currently taking immunosuppressant medication
* Women who have had a previous hysterectomy

Where it's running

  • Odette Cancer Centre
    Toronto, Ontario, Canada
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • E7 T-cell therapy for advanced HPV-related cancers

    This study is testing a new treatment using specially modified immune cells to see if it can help people with advanced cancers linked to HPV feel better and live longer.

    Recruiting at 2 sites Phase 1/2 Rutgers, The State University of New Jersey · New Brunswick, New Jersey and 1 other locations · NCT05639972

  • Testing trastuzumab deruxtecan (T‑DxD) for HER2‑positive advanced solid tumors

    This will test whether trastuzumab deruxtecan (T‑DxD) helps adults in the US with HER2‑positive (IHC 3+) locally advanced, unresectable, or metastatic solid tumors who have had prior systemic treatment and have no satisfactory alternative options.

    Recruiting at 18 sites AstraZeneca · Birmingham, Alabama and 17 other locations · NCT07124000

  • Immunotherapy using E7 TCR-T cells for HPV-related cancers

    This study is testing a new immunotherapy using E7 TCR-T cells to see if it can help people with advanced HPV-related cancers like cervical and throat cancer feel better and improve their health.

    Recruiting at 3 sites Phase 2 Rutgers, The State University of New Jersey · Bethesda, Maryland and 2 other locations · NCT05686226

  • Finding HPV DNA in the blood of people with anal or cervical cancer.

    This study will test whether a blood test can find HPV DNA in people with HPV-related anal or cervical cancer before, during, and after radiation treatment.

    Recruiting at 2 sites University of Chicago · Chicago, Illinois and 1 other locations · NCT04857528

  • Radiotherapy for gynecologic cancer with up to 10 metastatic sites

    This registry follows adults with gynecologic cancer who have 1 to 10 active metastatic lesions and are treated with radiotherapy as part of routine care to see how such treatments work in real-world settings.

    Recruiting Affidea Nu-med Center of Oncological DIagnostics and Therapy · Zamość · NCT07883798

  • Irreversible Electroporation for Recurrent Pelvic Tumors

    This study tests whether using irreversible electroporation (IRE) is safe and helps control recurrent pelvic tumors in adults who can’t have other local treatments.

    Recruiting Amsterdam UMC, location VUmc · Amsterdam, North Holland · NCT07782164

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.