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

Cervical Cancer Clinical Trial

— Vulvar-AIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03061435
• Other study ID #: GYNEOCC 3
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: February 1, 2025

Study information

• Verified date: April 2024
• Source: Sunnybrook Health Sciences Centre
• Contact: Nithla Mohanathas, BSc
• Phone: 4164805000
• Email: nithla.mohanathas[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: February 1, 2025
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anal Cancer
• Anal Dysplasia
• Anus Neoplasms
• Cervical Cancer
• Cervical Dysplasia
• HPV-Related Anal Squamous Cell Carcinoma
• Hyperplasia
• Uterine Cervical Dysplasia
• Uterine Cervical Neoplasms
• Vulvar Cancer
• Vulvar Dysplasia
• Vulvar Neoplasms

Intervention

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
• 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.

Locations

Country	Name	City	State
Canada	Odette Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Danielle Vicus

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of abnormal anal cytology and hrHPV DNA in women with VIN 2/3 or vulvar cancer		6 months to 1 year
Secondary	Prevalence of AIN in women with VIN 2/3 or vulvar cancer		6 months to 1 year
Secondary	Assess t he correlation between abnormal anal cytology, hrHPV DNA, and AIN		6 months to 1 year