Anal Dysplasia in Patients With Inflammatory Bowel Disease and Healthy Controls

Not Applicable

Completed

• Conditions: Anal Squamous Intraepithelial Lesion (ASIL); HPV DNA
• Interventions: Procedure: Anal Pap smear and HPV DNA testing

• Registration Number: NCT01860963
• Lead Sponsor: Stanford University

Brief 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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2013-05-21
• Study First Submitted QC: 2013-05-22
• Study First Posted: 2013-05-23
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-30
• Last Update Posted: 2013-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 310

Inclusion Criteria

• All IBD patients followed in the IBD clinic and healthy controls who are greater than 18 years old

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Exclusion Criteria

• History of HPV vaccination
• Pregnancy
• Other immunosuppressed states (i.e. systemic lupus erythematosus, rheumatoid arthritis, cancer, Human Immunodeficiency Virus (HIV), transplant)
• IBD patients who don't meet immunosuppression/non-immunosuppression criteria
• Inability to obtain informed consent from patient
• Previous diagnosis of ASIL or anal/rectal cancer

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IBD patients on immunosuppression	Anal Pap smear and HPV DNA testing	Patients on azathioprine/6-mercaptopurine (6MP), prednisone, methotrexate, infliximab, adalimumab, certolizumab, natalizumab, and etanercept are included.
IBD patients off immunosuppressants	Anal Pap smear and HPV DNA testing	Patients off immunosuppressants, on 5-aminosalicylic acid (5-ASA) agents, antibiotics, or no treatment for IBD are included.
Healthy controls	Anal Pap smear and HPV DNA testing	Age-matched healthy controls enrolled from the hospital, outpatient clinics, and from the general public via flyers and online advertisements.

Primary Outcome Measures

Name	Time	Method
Presence of high risk HPV and/or abnormal cytology	1 day

Trial Locations

Locations (1)

Stanford Digestive Health Center; 🇺🇸 Stanford, California, United States