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

Stanford University

Status

Completed

Conditions

HPV DNA

Anal Squamous Intraepithelial Lesion (ASIL)

Treatments

Procedure: Anal Pap smear and HPV DNA testing

Study type

Interventional

Funder types

Other

Identifiers

NCT01860963

MW-16467

Details and patient eligibility

About

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

Full 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.

Enrollment

310 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

310 participants in 3 patient groups

IBD patients on immunosuppression

Active Comparator group

Description:

Patients on azathioprine/6-mercaptopurine (6MP), prednisone, methotrexate, infliximab, adalimumab, certolizumab, natalizumab, and etanercept are included.

Treatment:

Procedure: Anal Pap smear and HPV DNA testing

IBD patients off immunosuppressants

Active Comparator group

Description:

Patients off immunosuppressants, on 5-aminosalicylic acid (5-ASA) agents, antibiotics, or no treatment for IBD are included.

Treatment:

Procedure: Anal Pap smear and HPV DNA testing

Healthy controls

Active Comparator group

Description:

Age-matched healthy controls enrolled from the hospital, outpatient clinics, and from the general public via flyers and online advertisements.