Anal Cancer, Anal Dysplasia, Cervical Cancer, Cervical Dysplasia, HPV-Related Anal Squamous Cell Carcinoma, Vulvar Cancer, Vulvar Dysplasia
Conditions
Keywords
Vulvar Cancer, Cervical Cancer, Vulvar Dysplasia, Cervical Dysplasia, Anal Cancer, Anal Dysplasia, HPV
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.
Interventions
PROCEDUREScreening anal Pap smear - No high-resolution anoscopy
75% of patients with negative cytology on their anal Pap smear will not receive high-resolution anoscopy
PROCEDUREScreening 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.
Sponsors
Dr. Danielle Vicus
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence of abnormal anal cytology and hrHPV DNA in women with VIN 2/3 or vulvar cancer | 6 months to 1 year |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Canada
Contacts
Primary ContactNithla Mohanathas, BSc
Backup ContactAnika Mohan, BSc
Outcome results
None listed