Overlooked Population at Risk for AIN.
Primary Purpose
High Grade Cervical Dysplasia, Cervical Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Screening Anal Pap Smear - No High Resolution Anoscopy
Screening Anal Pap Smear - With High Resolution Anoscopy
Sponsored by
About this trial
This is an interventional prevention trial for High Grade Cervical Dysplasia focused on measuring Cervical
Eligibility 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
Sites / Locations
- Odette Cancer Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Anal Screening Pap Smear - Negative
Anal Pap Smear - Positive Result - High Resolution Anoscopy
Arm Description
Anal Pap Smear with no High Resolution Anoscopy
Patient who have a positive anal pap smear will go on to have a high resolution anoscopy.
Outcomes
Primary Outcome Measures
Prevalence
Prevalence of anal dysplasia in women with high grade cervical dysplasia or cervical cancer. Calculated at screening all women with cervical dysplasia or cancer and performing high-resolution anoscopy on those diagnosed with dysplasia.
Secondary Outcome Measures
Full Information
NCT ID
NCT01953094
First Posted
August 26, 2013
Last Updated
May 11, 2021
Sponsor
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT01953094
Brief Title
Overlooked Population at Risk for AIN.
Official Title
The Overlooked Population at Risk for AIN: Women With High-grade Lower Genital Tract Dysplasia or Cervical Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Grade Cervical Dysplasia, Cervical Cancer
Keywords
Cervical
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anal Screening Pap Smear - Negative
Arm Type
Other
Arm Description
Anal Pap Smear with no High Resolution Anoscopy
Arm Title
Anal Pap Smear - Positive Result - High Resolution Anoscopy
Arm Type
Other
Arm Description
Patient who have a positive anal pap smear will go on to have a high resolution anoscopy.
Intervention Type
Procedure
Intervention Name(s)
Screening Anal Pap Smear - No High Resolution Anoscopy
Intervention Type
Procedure
Intervention Name(s)
Screening Anal Pap Smear - With High Resolution Anoscopy
Primary Outcome Measure Information:
Title
Prevalence
Description
Prevalence of anal dysplasia in women with high grade cervical dysplasia or cervical cancer. Calculated at screening all women with cervical dysplasia or cancer and performing high-resolution anoscopy on those diagnosed with dysplasia.
Time Frame
Screening and up to 24 weeks.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniell Vicus, MD
Organizational Affiliation
Odette Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odette Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Overlooked Population at Risk for AIN.
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