Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Screening anal Pap smear - No high-resolution anoscopy, Screening anal Pap smear - High-resolution anoscopy.
- Who it may be relevant to
- Registry conditions: Vulvar Cancer, Cervical Cancer, Vulvar Dysplasia, Cervical Dysplasia. Basic parameters: from 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Primary outcome measures
- Prevalence of abnormal anal cytology and hrHPV DNA in women with VIN 2/3 or vulvar cancer [Time frame: 6 months to 1 year]
Secondary outcome measures (2)
- Prevalence of AIN in women with VIN 2/3 or vulvar cancer [Time frame: 6 months to 1 year]
- Assess t he correlation between abnormal anal cytology, hrHPV DNA, and AIN [Time frame: 6 months to 1 year]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Canada · 1 center
- Odette Cancer Centre — Toronto
Identifiers
NCT: NCT03061435 · GYNEOCC 3