Overlooked Population at Risk for AIN.
Conditions
High Grade Cervical Dysplasia - Cervical Cancer
Conditions: official terms
Cervical Intraepithelial Neoplasia - Uterine Cervical Dysplasia - Uterine Cervical Neoplasms
Conditions: Keywords
Cervical
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Intervention
Name: Screening Anal Pap Smear - No High Resolution Anoscopy Type: Procedure
Name: Screening Anal Pap Smear - With High Resolution Anoscopy Type: Procedure
Overall Status
Recruiting
Summary
The purpose of this study is to determine the possibility and compliance of performing anal Pap smear and Human Papilloma Virus (HPV) DNA testing on women with high grade lower genital tract dysplasia or cervical cancer and determining the prevalence of anal dysplasia in this population using a high-resolution anoscopy (HRA). In addition, it is being done to potentially develop screening, diagnostic and treatment protocol for anal dysplasia in women with high-grade lower genital tract dysplasia or cervical cancer.
Detailed Description
Anal cancer incidence is increasing and although women compose more than half of all cases and those with HPV related lower genital tract dysplasia/malignancy have an even greater risk screening is currently not recommended. We therefore propose performing a prospective cohort study to determine the prevalence of anal dysplasia in women with high-grade lower genital tract dysplasia using high-resolution anoscopy HRA. This will then potentially lead to the development of a screening, diagnosis and treatment schema that can be implemented in all women with high-grade lower genital tract dysplasia. This study can potentially have a high impact on health delivery in women at high risk for anal cancer as this can transform the current treatment of anal cancer to a preventive screening program. This can later be implemented throughout Ontario and in all centers that treat women with cervical dysplasia.

The incidence of anal intraepithelial neoplasm (AIN also known as anal cancer) has increased in Ontario over the last 20 years. Two-thirds of the cases are found in women. The average time between diagnosis of anal cancer and previous cervical dysplasia or cancer is approximately 20 years. This study is giving the opportunity to detect and treat pre-invasive lesions and potentially prevent the development of anal cancer. Currently, no screening, diagnosis or treatment recommendation for anal dysplasia found in women with high-grade lower genital tract dysplasia.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: N/A
Minimum Age: 40 Years
Gender: Female
Criteria: Inclusion Criteria:

- Women ≥ 40 years old

- Previous or current high grade cervical dysplasia or cervical cancer

Exclusion Criteria:

- Women ≥ 40 years old because the median time between the diagnosis of anal cancer and previous cervical cancer is approximately 20 years.

- chemotherapy or radiation therapy within the last 6 months
Location
Odette Cancer Centre
Toronto, Ontario, Canada
Status: Recruiting
Contact: Jessica Marer - jessica.marer@sunnybrook.ca
Start Date
October 2014
Completion Date
December 2018
Sponsors
Sunnybrook Health Sciences Centre
Source
Sunnybrook Health Sciences Centre
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page