Anal Dysplasia in Patients With Inflammatory Bowel Disease

IBD Clinical Trial

— HPVIBD  

Official title:

The Incidence of Abnormal Anal Pap Smears in Patients With Inflammatory Bowel Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01653054
• Other study ID #: 11-01-050E
• Status: Completed
• Phase: N/A
• First received: July 26, 2012
• Last updated: April 24, 2018
• Start date: October 2011
• Est. completion date: September 29, 2015

Study information

• Verified date: April 2018
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 29, 2015
• Est. primary completion date: September 29, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• IBD
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Procedure:
• Anal Pap Smear, HPV DNA Testing
Anal Pap Smears and HPV DNA testing will be performed on all subjects.

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York
United States	Stony Brook University Hospital	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abnormal anal cytology and presence of high risk HPV DNA		1 day