Anal Dysplasia in Patients With Inflammatory Bowel Disease and Healthy Controls (ADIBD)

September 30, 2013 updated by: Stanford University

Prevalence of Anal Dysplasia in Patients With Inflammatory Bowel Disease and Healthy Controls

This study is designed to establish the prevalence of anal squamous intraepithelial lesion (ASIL) in patients with inflammatory bowel disease (IBD) and healthy controls.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

IBD patients attending the Stanford Inflammatory Bowel Disease (IBD) clinic and age-matched healthy controls are screened for eligibility. Informed consent is obtained for eligible subjects. An anonymous self-administered questionnaire is administered to assess risk factors for HPV. For IBD patients, information regarding IBD diagnosis and treatment is obtained.

An anal pap smear is performed at the time of a clinic visit or at the time of an already scheduled colonoscopy. Samples are collected and processed at Stanford pathology where a blinded pathologist reads all specimens. Human Papillomavirus (HPV) DNA testing is performed on all specimens. All patients with anal squamous intraepithelial lesion (ASIL) are referred to a colorectal surgeon for further recommendations or treatment, which includes a high-resolution anoscopy.

Study Type

Interventional

Enrollment (Anticipated)

310

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford Digestive Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All IBD patients followed in the IBD clinic and healthy controls who are greater than 18 years old

Exclusion Criteria:

  • History of HPV vaccination
  • Pregnancy
  • Other immunosuppressed states (i.e. systemic lupus erythematosus, rheumatoid arthritis, cancer, Human Immunodeficiency Virus (HIV), transplant)
  • IBD patients who don't meet immunosuppression/non-immunosuppression criteria
  • Inability to obtain informed consent from patient
  • Previous diagnosis of ASIL or anal/rectal cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: IBD patients on immunosuppression
Patients on azathioprine/6-mercaptopurine (6MP), prednisone, methotrexate, infliximab, adalimumab, certolizumab, natalizumab, and etanercept are included.
Procedure: Anal Pap smear and HPV DNA testing
Anal Pap smear is a standard diagnostic test used for early detection of pre-cancerous cells and anal HPV.
Active Comparator: IBD patients off immunosuppressants
Patients off immunosuppressants, on 5-aminosalicylic acid (5-ASA) agents, antibiotics, or no treatment for IBD are included.
Procedure: Anal Pap smear and HPV DNA testing
Anal Pap smear is a standard diagnostic test used for early detection of pre-cancerous cells and anal HPV.
Active Comparator: Healthy controls
Age-matched healthy controls enrolled from the hospital, outpatient clinics, and from the general public via flyers and online advertisements.
Procedure: Anal Pap smear and HPV DNA testing
Anal Pap smear is a standard diagnostic test used for early detection of pre-cancerous cells and anal HPV.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Presence of high risk HPV and/or abnormal cytology
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Mark Welton, MD, Stanford Hosptial and Clinics
  • Principal Investigator: Shamita Shah, MD, Stanford Hospital and Clinics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

May 21, 2013

First Submitted That Met QC Criteria

May 22, 2013

First Posted (Estimate)

May 23, 2013

Study Record Updates

Last Update Posted (Estimate)

October 1, 2013

Last Update Submitted That Met QC Criteria

September 30, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MW-16467

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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