Overlooked Population at Risk for AIN.

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01953094
• Other study ID #: GYNEOCC 1
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: December 2021

Study information

• Verified date: April 2024
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 355
• Est. completion date: December 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• High Grade Cervical Dysplasia
• Uterine Cervical Dysplasia
• Uterine Cervical Neoplasms

Intervention

Procedure:
• Screening Anal Pap Smear - No High Resolution Anoscopy

• Screening Anal Pap Smear - With High Resolution Anoscopy

Locations

Country	Name	City	State
Canada	Odette Cancer Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence	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.	Screening and up to 24 weeks.