Overlooked Population at Risk for AIN.

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2013 by Sunnybrook Health Sciences Centre
Sponsor:
Information provided by (Responsible Party):
Dr. Danielle Vicus, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01953094
First received: August 26, 2013
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

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 Intervention
High Grade Cervical Dysplasia
Cervical Cancer
Procedure: Screening Anal Pap Smear - No High Resolution Anoscopy
Procedure: Screening Anal Pap Smear - With High Resolution Anoscopy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • Prevalence [ Time Frame: Screening and up to 24 weeks. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 300
Study Start Date: October 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01953094

Contacts
Contact: Jessica Marer, Clinical Research Associate 416-480-5000 ext 7387 jessica.marer@sunnybrook.ca

Locations
Canada, Ontario
Odette Cancer Centre Not yet recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Jessica Marer       jessica.marer@sunnybrook.ca   
Principal Investigator: Danielle Vicus, MD         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Daniell Vicus, MD Odette Cancer Centre
  More Information

No publications provided

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
Study First Received: August 26, 2013
Last Updated: September 25, 2013
Health Authority: Canada: Health Canada

Keywords provided by 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

ClinicalTrials.gov processed this record on August 21, 2014