Anal Dysplasia in Patients With Inflammatory Bowel Disease and Healthy Controls
ADIBD
Prevalence of Anal Dysplasia in Patients With Inflammatory Bowel Disease and Healthy Controls
1 other identifier
interventional
310
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 21, 2013
CompletedFirst Posted
Study publicly available on registry
May 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedOctober 1, 2013
September 1, 2013
3.4 years
May 21, 2013
September 30, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Presence of high risk HPV and/or abnormal cytology
1 day
Study Arms (3)
IBD patients on immunosuppression
ACTIVE COMPARATORPatients on azathioprine/6-mercaptopurine (6MP), prednisone, methotrexate, infliximab, adalimumab, certolizumab, natalizumab, and etanercept are included.
IBD patients off immunosuppressants
ACTIVE COMPARATORPatients off immunosuppressants, on 5-aminosalicylic acid (5-ASA) agents, antibiotics, or no treatment for IBD are included.
Healthy controls
ACTIVE COMPARATORAge-matched healthy controls enrolled from the hospital, outpatient clinics, and from the general public via flyers and online advertisements.
Interventions
Anal Pap smear is a standard diagnostic test used for early detection of pre-cancerous cells and anal HPV.
Eligibility Criteria
You may qualify if:
- All IBD patients followed in the IBD clinic and healthy controls who are greater than 18 years old
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford Digestive Health Center
Stanford, California, 94305, United States
Related Publications (1)
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.
PMID: 26044314DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Welton, MD
Stanford Hosptial and Clinics
- PRINCIPAL INVESTIGATOR
Shamita Shah, MD
Stanford Hospital and Clinics
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2013
First Posted
May 23, 2013
Study Start
January 1, 2010
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
October 1, 2013
Record last verified: 2013-09