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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBD patients on immunosuppression | Active Comparator | Patients on azathioprine/6-mercaptopurine (6MP), prednisone, methotrexate, infliximab, adalimumab, certolizumab, natalizumab, and etanercept are included. |
|
| IBD patients off immunosuppressants | Active Comparator | Patients off immunosuppressants, on 5-aminosalicylic acid (5-ASA) agents, antibiotics, or no treatment for IBD are included. |
|
| Healthy controls | Active Comparator | Age-matched healthy controls enrolled from the hospital, outpatient clinics, and from the general public via flyers and online advertisements. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anal Pap smear and HPV DNA testing | Procedure | Anal Pap smear is a standard diagnostic test used for early detection of pre-cancerous cells and anal HPV. |
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| Measure | Description | Time Frame |
|---|---|---|
| Presence of high risk HPV and/or abnormal cytology | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Welton, MD | Stanford Hosptial and Clinics | Principal Investigator |
| Shamita Shah, MD | Stanford Hospital and Clinics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Digestive Health Center | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26044314 | Derived | Shah SB, Pickham D, Araya H, Kamal A, Pineda CE, Ghole S, Shih L, Kong C, Pai R, Welton M. Prevalence of Anal Dysplasia in Patients With Inflammatory Bowel Disease. Clin Gastroenterol Hepatol. 2015 Nov;13(11):1955-61.e1. doi: 10.1016/j.cgh.2015.05.031. Epub 2015 Jun 2. |
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