Anal Dysplasia in Patients With Inflammatory Bowel Disease

NCT01653054 | Completed

• 1 other identifier: 11-01-050E
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

IBD

Outcome Measures

Primary Outcomes (1)

• Abnormal anal cytology and presence of high risk HPV DNA

  1 day

Study Arms (2)

IBD patients ON Immunosuppression

EXPERIMENTAL

Procedure: Anal Pap Smear, HPV DNA Testing

IBD Patients OFF Immunosuppression

EXPERIMENTAL

Procedure: Anal Pap Smear, HPV DNA Testing

Interventions

Anal Pap Smear, HPV DNA Testing PROCEDURE

Anal Pap Smears and HPV DNA testing will be performed on all subjects.

IBD Patients OFF Immunosuppression; IBD patients ON Immunosuppression

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (2)

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Study Officials

• Lawrence Brandt, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2012
• First Posted: July 30, 2012
• Study Start: October 1, 2011
• Primary Completion: September 29, 2015
• Study Completion: September 29, 2015
• Last Updated: April 25, 2018

Record last verified: 2018-04

Locations

US (2)