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

NCT03061435 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-05-16

No results posted yet for this study

Summary

Almost half of all women will develop an HPV infection in their lifetime. While most infections are naturally asymptomatic or cleared by the immune system, some persist and can lead to the development of cervical, vulvar, or anal lesions and eventually cancer. Screening regimens for these lesions are currently only in place for the cervix through regular Pap tests. These Pap tests usually involve an examination of the vulva -however, no screening procedures exist for anal cancer for women. Several studies have suggested that women with existing gynecological lesions are more likely to develop anal lesions and anal cancer. Here the investigators propose a multi-center study which seeks to screen for and treat anal cancer in women over the age of 40 with vulvar lesions and a stable immune system. The investigators will achieve this through performing anal Pap smears on eligible women and conducting High Resolution Anoscopy (HRA) and appropriate treatment procedures on those with abnormal anal cells. With enough evidence, there may be an indication to establish regular anal cancer screening measures in this potentially underserved population.

Hypothesis: The investigators hypothesize that at least 40% of women with vulvar cancer or VIN2/3 will have abnormal anal cytology. 35% of the population will be hrHPV DNA positive and 11% will additionally have AIN2/3. This prospective study may lay the groundwork for routine anal screening regimens in Ontario and help shift health policy to treat this population.

Conditions

  • Vulvar Cancer
  • Cervical Cancer
  • Vulvar Dysplasia
  • Cervical Dysplasia
  • Anal Cancer
  • Anal Dysplasia
  • HPV-Related Anal Squamous Cell Carcinoma

Interventions

PROCEDURE

Screening anal Pap smear - No high-resolution anoscopy

75% of patients with negative cytology on their anal Pap smear will not receive high-resolution anoscopy

PROCEDURE

Screening anal Pap smear - High-resolution anoscopy

25% of patients with negative cytology on their anal Pap smear will receive high-resolution anoscopy. All patients with positive (abnormal) cytology on their anal Pap smear will receive high-resolution anoscopy.

Sponsors & Collaborators

  • Dr. Danielle Vicus

    lead OTHER

Principal Investigators

  • Danielle Vicus, MD · Odette Cancer Centre

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2025-08-01
Completion
2026-01-01

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03061435 on ClinicalTrials.gov