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Anal Dysplasia in Patients With Inflammatory Bowel Disease and Healthy Controls

Information source: Stanford University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anal Squamous Intraepithelial Lesion (ASIL); HPV DNA

Intervention: Anal Pap smear and HPV DNA testing (Procedure)

Phase: N/A

Status: Completed

Sponsored by: Stanford University

Official(s) and/or principal investigator(s):
Mark Welton, MD, Principal Investigator, Affiliation: Stanford Hosptial and Clinics
Shamita Shah, MD, Principal Investigator, Affiliation: Stanford Hospital and Clinics


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

Clinical Details

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

Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening

Primary outcome: Presence of high risk HPV and/or abnormal cytology

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.


Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.


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

Locations and Contacts

Stanford Digestive Health Center, Stanford, California 94305, United States
Additional Information

Starting date: January 2010
Last updated: September 30, 2013

Page last updated: August 23, 2015

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