Anal Dysplasia in Patients With Inflammatory Bowel Disease and Healthy Controls

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anal Squamous Intraepithelial Lesion (ASIL), HPV DNA

Intervention / Treatment
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* Procedure: Anal Pap smear and HPV DNA testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All IBD patients followed in the IBD clinic and healthy controls who are greater than 18 years old 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IBD patients on immunosuppression<br>Patients on azathioprine/6-mercaptopurine (6MP), prednisone, methotrexate, infliximab, adalimumab, certolizumab, natalizumab, and etanercept are included. | Procedure: Anal Pap smear and HPV DNA testing<br>* Anal Pap smear is a standard diagnostic test used for early detection of pre-cancerous cells and anal HPV.<br>|
| Active Comparator: IBD patients off immunosuppressants<br>Patients off immunosuppressants, on 5-aminosalicylic acid (5-ASA) agents, antibiotics, or no treatment for IBD are included. | Procedure: Anal Pap smear and HPV DNA testing<br>* Anal Pap smear is a standard diagnostic test used for early detection of pre-cancerous cells and anal HPV.<br>|
| Active Comparator: Healthy controls<br>Age-matched healthy controls enrolled from the hospital, outpatient clinics, and from the general public via flyers and online advertisements. | Procedure: Anal Pap smear and HPV DNA testing<br>* Anal Pap smear is a standard diagnostic test used for early detection of pre-cancerous cells and anal HPV.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of high risk HPV and/or abnormal cytology |  | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASIL, Anal dysplasia, IBD, HPV DNA