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

Who is this study for? Older adult female patients with High Grade 2 or 3 Squamous Intraepithelial Lesions or Vulvar Cancer
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 40
Healthy Volunteers: t
View:

• Women age ≥ 40

• Previous diagnosis of VIN 2/3 or vulvar

Locations
Other Locations
Canada
Odette Cancer Centre
RECRUITING
Toronto
Contact Information
Primary
Nithla Mohanathas, BSc
nithla.mohanathas@sunnybrook.ca
4164805000
Backup
Anika Mohan, BSc
anika.mohan@sunnybrook.ca
4164805000
Time Frame
Start Date: 2021-02-01
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 110
Treatments
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.
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.
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.
Sponsors
Leads: Dr. Danielle Vicus

This content was sourced from clinicaltrials.gov