Overlooked Population at Risk for AIN.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

355 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2021-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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High Grade Cervical Dysplasia Cervical Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Anal Screening Pap Smear - Negative

Anal Pap Smear with no High Resolution Anoscopy

Group Type OTHER

Screening Anal Pap Smear - No High Resolution Anoscopy

Intervention Type PROCEDURE

Anal Pap Smear - Positive Result - High Resolution Anoscopy

Patient who have a positive anal pap smear will go on to have a high resolution anoscopy.

Group Type OTHER

Screening Anal Pap Smear - With High Resolution Anoscopy

Intervention Type PROCEDURE

Interventions

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Screening Anal Pap Smear - No High Resolution Anoscopy

Intervention Type PROCEDURE

Screening Anal Pap Smear - With High Resolution Anoscopy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes