Anal Dysplasia in Patients With Inflammatory Bowel Disease and Healthy Controls — ADIBD  

HPV DNA Clinical Trial

Official title: Prevalence of Anal Dysplasia in Patients With Inflammatory Bowel Disease and Healthy Controls

Status Completed

Clinical Trial Summary

This study is designed to establish the prevalence of anal squamous intraepithelial lesion (ASIL) in patients with inflammatory bowel disease (IBD) and healthy controls.

Clinical Trial Description

IBD patients attending the Stanford Inflammatory Bowel Disease (IBD) clinic and age-matched healthy controls are screened for eligibility. Informed consent is obtained for eligible subjects. An anonymous self-administered questionnaire is administered to assess risk factors for HPV. For IBD patients, information regarding IBD diagnosis and treatment is obtained.

An anal pap smear is performed at the time of a clinic visit or at the time of an already scheduled colonoscopy. Samples are collected and processed at Stanford pathology where a blinded pathologist reads all specimens. Human Papillomavirus (HPV) DNA testing is performed on all specimens. All patients with anal squamous intraepithelial lesion (ASIL) are referred to a colorectal surgeon for further recommendations or treatment, which includes a high-resolution anoscopy. ;

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

• Anal Squamous Intraepithelial Lesion (ASIL)
• HPV DNA
• Inflammatory Bowel Diseases

• NCT number: NCT01860963
• Study type: Interventional
• Source: Stanford University
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Completion date: June 2013