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

Primary Purpose

Anal Squamous Intraepithelial Lesion (ASIL), HPV DNA

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Anal Pap smear and HPV DNA testing

About this trial

This is an interventional screening trial for Anal Squamous Intraepithelial Lesion (ASIL) focused on measuring ASIL, Anal dysplasia, IBD, HPV DNA

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Stanford Digestive Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

IBD patients on immunosuppression

IBD patients off immunosuppressants

Healthy controls

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Presence of high risk HPV and/or abnormal cytology

Secondary Outcome Measures

Full Information

NCT ID

NCT01860963

First Posted

May 21, 2013

Last Updated

September 30, 2013

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT01860963

Brief Title

Anal Dysplasia in Patients With Inflammatory Bowel Disease and Healthy Controls

Acronym

ADIBD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Stanford University

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anal Squamous Intraepithelial Lesion (ASIL), HPV DNA

Keywords

ASIL, Anal dysplasia, IBD, HPV DNA

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Non-Randomized

Enrollment

310 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

IBD patients on immunosuppression

Arm Type

Active Comparator

Arm Description

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

Arm Title

IBD patients off immunosuppressants

Arm Type

Active Comparator

Arm Description

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

Arm Title

Healthy controls

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Anal Pap smear and HPV DNA testing

Intervention Description

Anal Pap smear is a standard diagnostic test used for early detection of pre-cancerous cells and anal HPV.

Primary Outcome Measure Information:

Title

Presence of high risk HPV and/or abnormal cytology

Time Frame

1 day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Welton, MD

Organizational Affiliation

Stanford Hosptial and Clinics

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Shamita Shah, MD

Organizational Affiliation

Stanford Hospital and Clinics

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford Digestive Health Center

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

26044314

Citation

Shah SB, Pickham D, Araya H, Kamal A, Pineda CE, Ghole S, Shih L, Kong C, Pai R, Welton M. Prevalence of Anal Dysplasia in Patients With Inflammatory Bowel Disease. Clin Gastroenterol Hepatol. 2015 Nov;13(11):1955-61.e1. doi: 10.1016/j.cgh.2015.05.031. Epub 2015 Jun 2.

Results Reference

derived

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Anal Dysplasia in Patients With Inflammatory Bowel Disease and Healthy Controls

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