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

Sponsor

Stanford University (Other)

Overall Status

Completed

CT.gov ID

NCT01860963

Collaborator

(none)

310

Enrollment

Location

Arms

Duration (Months)

7.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Anal Squamous Intraepithelial Lesion (ASIL) HPV DNA	Procedure: Anal Pap smear and HPV DNA testing	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

310 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Screening

Official Title:

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

Study Start Date :

Jan 1, 2010

Actual Primary Completion Date :

Jun 1, 2013

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Presence of high risk HPV and/or abnormal cytology [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford Digestive Health Center	Stanford	California	United States	94305

Sponsors and Collaborators

Stanford University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stanford University

ClinicalTrials.gov Identifier:

NCT01860963

Other Study ID Numbers:

MW-16467

First Posted:

May 23, 2013

Last Update Posted:

Oct 1, 2013

Last Verified:

Sep 1, 2013

Keywords provided by Stanford University

Additional relevant MeSH terms:

Inflammatory Bowel Diseases

Study Results

No Results Posted as of Oct 1, 2013