Anal Dysplasia in Patients With Inflammatory Bowel Disease
Condition: IBD
MeSH terms: Inflammatory Bowel Diseases
Study type: Interventional

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.
    

Detailed description: 
      IBD patients on and off immunosuppression will be identified from gastroenterology fellow
      clinics. After patients express interest in the study, a study coordinator will provide an
      overview of the study and obtain consent prior to initiating any research related procedures.
      Anal Pap smears and Digene Hybrid Capture 2 High-Risk HPV DNA Tests will be performed on each
      study patient.

      Medications will be documented for all IBD subjects and controls. Patient characteristics
      that will be documented will include IBD diagnosis, area of involvement (small bowel vs.
      large bowel, rectal involvement), type and duration of immunosuppressant use, smoking status,
      family history of any dysplasia (including anus), and reproductive risk factors. Data will be
      reported by subjects in subject interviews and through questionnaires.

      For the purposes of analysis, subjects will be divided into two groups: IBD patients on
      immunosuppression and IBD patients not on immunosuppression. Results will be recorded in
      relation to exposure to immunosuppressive agents including prednisone, purine analogs
      (azathioprine/6MP), methotrexate, and infliximab. Immunosuppression will be defined as a
      history of 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. Since this
      is a pilot project, we will recruit a minimum of 20 subjects to each group.

      Abnormalities will be classified in standard Bethesda classifications as atypical squamous
      cells of undetermined significance (ASCUS), low grade squamous intraepithelial lesion (LSIL),
      high grade squamous intraepithelial lesion (HSIL) or carcinoma. The pathologist reading the
      Pap smears will be blinded to the patient status (IBD versus control) and immunomodulator
      history.
    

Intervention name(s): Anal Pap Smear, HPV DNA Testing
Intervention type(s): Procedure
Intervention description(s): Anal Pap Smears and HPV DNA testing will be performed on all subjects.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic