Brief Title
Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer.
Official Title
Screening for Anal Cancer in Women With High-grade Vulvar Dysplasia or Vulvar Cancer.
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.
Study Type
Interventional
Primary Outcome
Prevalence of abnormal anal cytology and hrHPV DNA in women with VIN 2/3 or vulvar cancer
Secondary Outcome
Prevalence of AIN in women with VIN 2/3 or vulvar cancer
Condition
Vulvar Cancer
Intervention
Screening anal Pap smear - No high-resolution anoscopy
Study Arms / Comparison Groups
Screening anal Pap Smear - Negative (75%)
Description: All patients will receive an anal Pap test. 75% of patients with a negative anal Pap will complete study with no further intervention.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
110
Start Date
February 1, 2021
Completion Date
February 1, 2023
Primary Completion Date
February 1, 2022
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
Gender
Female
Ages
40 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Danielle Vicus, MD, 4164805000, [email protected]
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT03061435
Organization ID
GYNEOCC 3
Responsible Party
Sponsor-Investigator
Study Sponsor
Dr. Danielle Vicus
Study Sponsor
Danielle Vicus, MD, Principal Investigator, Odette Cancer Centre
Verification Date
May 2021