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

Dr. Danielle Vicus

Status: Enrolling

Conditions: Anal Cancer; HPV-Related Anal Squamous Cell Carcinoma; Vulvar Cancer; Vulvar Dysplasia; Cervical Dysplasia; Anal Dysplasia; Cervical Cancer

Treatments: Procedure: Screening anal Pap smear - No high-resolution anoscopy; Procedure: Screening anal Pap smear - High-resolution anoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT03061435

GYNEOCC 3

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: Female

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 3 patient groups

Screening anal Pap Smear - Negative (75%)

Other group

Description:

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

Treatment:

Procedure: Screening anal Pap smear - No high-resolution anoscopy

Screening anal Pap Smear - Negative (25%)

Other group

Description:

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.

Treatment:

Procedure: Screening anal Pap smear - High-resolution anoscopy

Screening anal Pap Smear - Positive

Other group

Description:

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.

Treatment:

Procedure: Screening anal Pap smear - High-resolution anoscopy