Anal Dysplasia in Patients With Inflammatory Bowel Disease (HPVIBD)

This study is currently recruiting participants.
Verified June 2012 by Montefiore Medical Center
Sponsor:
Information provided by (Responsible Party):
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT01653054
First received: July 26, 2012
Last updated: July 27, 2012
Last verified: June 2012
  Purpose

The rationale for this study is that the risk of anal dysplasia in patients with inflammatory bowel disease 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.


Condition Intervention
IBD
Procedure: Anal Pap Smear, HPV DNA Testing

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Incidence of Abnormal Anal Pap Smears in Patients With Inflammatory Bowel Disease

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Abnormal anal cytology and presence of high risk HPV DNA [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: October 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IBD patients ON Immunosuppression Procedure: Anal Pap Smear, HPV DNA Testing
Anal Pap Smears and HPV DNA testing will be performed on all subjects.
Experimental: IBD Patients OFF Immunosuppression Procedure: Anal Pap Smear, HPV DNA Testing
Anal Pap Smears and HPV DNA testing will be performed on all subjects.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01653054

Contacts
Contact: Jennifer Hsieh, MD 443-983-6533 jhsieh@montefiore.org
Contact: Mustafa Alani 718-920-6268 malani@montefiore.org

Locations
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Lawrence Brandt, MD    718-920-4846    lbrandt@montefiore.org   
Contact: Jennifer Hsieh, MD    443-983-6533    jhsieh@montefiore.org   
Principal Investigator: Lawrence Brandt, MD         
Sub-Investigator: Jennifer Hsieh, MD         
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Lawrence Brandt, MD Montefiore Medical Center
  More Information

No publications provided

Responsible Party: Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01653054     History of Changes
Other Study ID Numbers: Merck IISP 40090/MMC11-01-050E
Study First Received: July 26, 2012
Last Updated: July 27, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Intestinal Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 16, 2014