Clinical trial NCT01953094: Overlooked Population at Risk for AIN.
Official title: The Overlooked Population at Risk for AIN: Women With High-grade Lower Genital Tract Dysplasia or Cervical Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Grade Cervical Dysplasia
Cervical Cancer
Keywords: Cervical
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2013-09-30
Enrollment: 355
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: Prevalence
timeFrame: Screening and up to 24 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Odette Cancer Centre
state: Ontario
Study officials:
affiliation: Odette Cancer Centre
name: Daniell Vicus, MD
role: PRINCIPAL_INVESTIGATOR
References: