Anal Dysplasia in Patients With Inflammatory Bowel Disease

Completed · Not applicable

Conditions studied: IBD

In brief

The rationale for this study is that the risk of anal dysplasia in patients with inflammatory bowel disease (IBD) as compared to the general population has yet to be investigated prospectively. There have only been a few articles examining this relationship - preliminary results have suggested that patients with IBD are at increased risk for abnormal anal pap smears. As high grade anal dysplasia is strongly associated with an increased risk of anal carcinoma, it is important to identify all high risk groups that might benefit from routine screening. This pilot study aims to determine whether patients with IBD in our Bronx population have an increased risk of abnormal anal Pap smears. We hypothesize that there will be an increased incidence of abnormal anal pap smears in patients with IBD who have been treated with immunosuppressants, given that chronic immunosuppression is related to increased HPV infection.

Key facts

Study ID

NCT01653054

Run by

Montefiore Medical Center

People needed

40

Starts

2011-10-01

Expected to finish

2015-09-29

Last updated by the study team

2018-04-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• i. Women and men between the ages of 18-65 with a history of inflammatory bowel disease confirmed histologically and on immunosuppression defined as at least three months of azathioprine/6MP, eight consecutive weeks of prednisone greater than 15mg per day, a cumulative dose of greater than 100mg of methotrexate, or at least one infusion of infliximab within 8 weeks of the date of the anal Pap smear.
• ii. Women and men between the ages of 18-65 with a history of inflammatory bowel disease confirmed histologically and not on immunosuppression (defined as above)

You may not qualify if…

• i. Patients with HIV, transplant recipients, men who have sex with men as they already represent high risk groups ii. Women with a history of an abnormal cervical Pap test within the past 2 years.
• iii. Patients with active proctitis as defined by an abnormal sigmoidoscopy or colonoscopy, rectal bleeding or tenesmus.

Where it is running

• Stony Brook University Hospital — Stony Brook, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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