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

Sponsor

Dr. Danielle Vicus (Other)

Overall Status

Recruiting

CT.gov ID

NCT03061435

Collaborator

(none)

110

Enrollment

Location

Arms

Anticipated Duration (Months)

4.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vulvar Cancer Cervical Cancer Vulvar Dysplasia Cervical Dysplasia Anal Cancer Anal Dysplasia HPV-Related Anal Squamous Cell Carcinoma	Procedure: Screening anal Pap smear - No high-resolution anoscopy Procedure: Screening anal Pap smear - High-resolution anoscopy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

110 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Actual Study Start Date :

Feb 1, 2021

Anticipated Primary Completion Date :

Feb 1, 2022

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.	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
Other: 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.	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.
Other: 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.	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.

Arm

Intervention/Treatment

Other: 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.

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

Other: 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.

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.

Other: 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.

Procedure: Screening anal Pap smear - High-resolution anoscopy

Outcome Measures

Primary Outcome Measures

Prevalence of abnormal anal cytology and hrHPV DNA in women with VIN 2/3 or vulvar cancer [6 months to 1 year]

Secondary Outcome Measures

Prevalence of AIN in women with VIN 2/3 or vulvar cancer [6 months to 1 year]
Assess t he correlation between abnormal anal cytology, hrHPV DNA, and AIN [6 months to 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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