Overlooked Population at Risk for AIN.

NCT01953094 | Completed

• 1 other identifier: GYNEOCC 1
• Study Type: interventional
• Target: 355
• Locations: 1 country
• Sites: 1

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.

Conditions

High Grade Cervical Dysplasia; Cervical Cancer

Keywords

Cervical

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Anal Screening Pap Smear - Negative

OTHER

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

OTHER

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

Interventions

Screening Anal Pap Smear - No High Resolution Anoscopy PROCEDURE

Anal Screening Pap Smear - Negative

Screening Anal Pap Smear - With High Resolution Anoscopy PROCEDURE

Anal Pap Smear - Positive Result - High Resolution Anoscopy

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women ≥ 40 years old
• Previous or current high grade cervical dysplasia or cervical cancer

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Daniell Vicus, MD

  Odette Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgical Oncologist in Gynecology Site Group

Study Record Dates

• First Submitted: August 26, 2013
• First Posted: September 30, 2013
• Study Start: October 1, 2014
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

CA (1)