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

NCT ID: NCT03061435

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2026-01-01

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Screening anal Pap Smear - Negative (75%)

All patients will receive an anal Pap test. 75% of patients with a negative anal Pap will complete study with no further intervention.

Group Type: OTHER

Screening anal Pap smear - No high-resolution anoscopy

Intervention Type: PROCEDURE

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

Screening anal Pap Smear - Negative (25%)

All patients will receive an anal Pap test. Remaining 25% of patients will proceed to high-resolution anoscopy (HRA) clinic to assess the negative predictive rate of HRA.

Group Type: OTHER

Screening anal Pap smear - High-resolution anoscopy

Intervention Type: PROCEDURE

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.

Screening anal Pap Smear - Positive

All patients will receive an anal Pap test. Any patient with abnormal cytology on their Pap test will be referred to HRA clinic for management. This includes potential biopsy and treatment.

Group Type: OTHER

Screening anal Pap smear - High-resolution anoscopy

Intervention Type: PROCEDURE

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.

Interventions

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

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Dr. Danielle Vicus

OTHER

Sponsor Role: lead

Responsible Party

Dr. Danielle Vicus

Dr. Danielle Vicus, MD, MSc, FRCSC

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Danielle Vicus, MD

Role: PRINCIPAL_INVESTIGATOR

Odette Cancer Centre

Locations

Odette Cancer Centre

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Nithla Mohanathas, BSc

Role: CONTACT

nithla.mohanathas@sunnybrook.ca

4164805000 ext. 85838

Anika Mohan, BSc

Role: CONTACT

anika.mohan@sunnybrook.ca

4164805000 ext. 89828

Other Identifiers

GYNEOCC 3

Identifier Type: -

Identifier Source: org_study_id