NCT01860963

Anal Dysplasia in Patients With Inflammatory Bowel Disease and Healthy Controls

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 310 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Anal Squamous Intraepithelial Lesion (ASIL)
• HPV DNA

Interventions

Type	Name	Description
PROCEDURE	Anal Pap smear and HPV DNA testing	Anal Pap smear is a standard diagnostic test used for early detection of pre-cancerous cells and anal HPV.

Timeline

• Start date: 2010-01-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2013-05-23
• Last updated: 2013-10-01

Locations

1 site across 1 country: United States