Anal Dysplasia in Patients With Inflammatory Bowel Disease and Healthy Controls
NCT ID: NCT01860963
Last Updated: 2013-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
310 participants
INTERVENTIONAL
2010-01-31
2013-06-30
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
SCREENING
SINGLE
Study Groups
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IBD patients on immunosuppression
Patients on azathioprine/6-mercaptopurine (6MP), prednisone, methotrexate, infliximab, adalimumab, certolizumab, natalizumab, and etanercept are included.
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.
IBD patients off immunosuppressants
Patients off immunosuppressants, on 5-aminosalicylic acid (5-ASA) agents, antibiotics, or no treatment for IBD are included.
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.
Healthy controls
Age-matched healthy controls enrolled from the hospital, outpatient clinics, and from the general public via flyers and online advertisements.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
85 Years
ALL
Yes
Sponsors
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Stanford University
OTHER
Responsible Party
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Principal Investigators
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Mark Welton, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford Hosptial and Clinics
Shamita Shah, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford Hospital and Clinics
Locations
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Stanford Digestive Health Center
Stanford, California, United States
Countries
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References
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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.
Other Identifiers
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MW-16467
Identifier Type: -
Identifier Source: org_study_id