Overlooked Population at Risk for AIN.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01953094|
Recruitment Status : Recruiting
First Posted : September 30, 2013
Last Update Posted : October 9, 2017
|Condition or disease||Intervention/treatment|
|High Grade Cervical Dysplasia Cervical Cancer||Procedure: Screening Anal Pap Smear - No High Resolution Anoscopy Procedure: Screening Anal Pap Smear - With High Resolution Anoscopy|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Overlooked Population at Risk for AIN: Women With High-grade Lower Genital Tract Dysplasia or Cervical Cancer.|
|Study Start Date :||October 2014|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||January 2019|
Anal Screening Pap Smear - Negative
Anal Pap Smear with no High Resolution Anoscopy
|Procedure: Screening Anal Pap Smear - No High Resolution Anoscopy|
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.
|Procedure: Screening Anal Pap Smear - With High Resolution Anoscopy|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01953094
|Contact: Sasha Manohar, Clinical Research Associate||416-480-5000 ext firstname.lastname@example.org|
|Odette Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M4N 3M5|
|Contact: Sasha Manohar email@example.com|
|Principal Investigator: Danielle Vicus, MD|
|Principal Investigator:||Daniell Vicus, MD||Odette Cancer Centre|