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OpenTrials
Completed

NCT Number: NCT01953094

Overlooked Population at Risk for AIN.

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Screening Anal Pap Smear - No High Resolution Anoscopy

Procedure

Screening Anal Pap Smear - With High Resolution Anoscopy

Procedure

Primary outcomes

  1. Prevalence

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Official study title

The Overlooked Population at Risk for AIN: Women With High-grade Lower Genital Tract Dysplasia or Cervical Cancer.

Important dates

Study start
2014
Primary completion
2020
Study completion
2021
First posted
Sep 30, 2013
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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