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Overlooked Population at Risk for AIN.

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ClinicalTrials.gov Identifier: NCT01953094
Recruitment Status : Recruiting
First Posted : September 30, 2013
Last Update Posted : October 9, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Danielle Vicus, 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.

Condition or disease Intervention/treatment Phase
High Grade Cervical Dysplasia Cervical Cancer Procedure: Screening Anal Pap Smear - No High Resolution Anoscopy Procedure: Screening Anal Pap Smear - With High Resolution Anoscopy Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01953094


Contacts
Contact: Sasha Manohar, Clinical Research Associate 416-480-5000 ext 7387 sasha.manohar@sunnybrook.ca

Locations
Canada, Ontario
Odette Cancer Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Sasha Manohar       sasha.manohar@sunnybrook.ca   
Principal Investigator: Danielle Vicus, MD         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Daniell Vicus, MD Odette Cancer Centre

Responsible Party: Dr. Danielle Vicus, Surgical Oncologist in Gynecology Site Group, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01953094     History of Changes
Other Study ID Numbers: GYNEOCC 1
First Posted: September 30, 2013    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017

Keywords provided by Dr. Danielle Vicus, Sunnybrook Health Sciences Centre:
Cervical

Additional relevant MeSH terms:
Uterine Cervical Dysplasia
Uterine Cervical Neoplasms
Cervical Intraepithelial Neoplasia
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Precancerous Conditions
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type