Overlooked Population at Risk for AIN.

Not Applicable

Completed

• Conditions: High Grade Cervical Dysplasia; Cervical Cancer
• Interventions: Procedure: Screening Anal Pap Smear - With High Resolution Anoscopy; Procedure: Screening Anal Pap Smear - No High Resolution Anoscopy

• Registration Number: NCT01953094
• Lead Sponsor: Sunnybrook Health Sciences Centre

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.

Study Timeline

• Study First Submitted: 2013-08-26
• Study First Submitted QC: 2013-09-25
• Study First Posted: 2013-09-30
• Study Start: 2014-10
• Primary Completion: 2020-12
• Study Completion: 2021-12
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 355

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anal Pap Smear - Positive Result - High Resolution Anoscopy	Screening Anal Pap Smear - With High Resolution Anoscopy	Patient who have a positive anal pap smear will go on to have a high resolution anoscopy.
Anal Screening Pap Smear - Negative	Screening Anal Pap Smear - No High Resolution Anoscopy	Anal Pap Smear with no High Resolution Anoscopy

Primary Outcome Measures

Name	Time	Method
Prevalence	Screening and up to 24 weeks.	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.

Trial Locations

Locations (1)

Odette Cancer Centre; 🇨🇦 Toronto, Ontario, Canada