Status:
COMPLETED
Precision Crohn's Disease Management Utilizing Predictive Protein Panels (ENvISION)
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
The Leona M. and Harry B. Helmsley Charitable Trust
Conditions:
Crohn's Disease
IBD
Eligibility:
All Genders
1-22 years
Brief Summary
Crohn's disease and ulcerative colitis affect about 1.6 to 3 million people in the United States with many of those being young children and adolescents. Physicians need better ways to inform decision...
Detailed Description
Despite the heterogeneity of CD phenotypes and a potentially aggressive course of inadequately treated CD, treatment selection for newly diagnosed patients is currently based on clinical factors which...
Eligibility Criteria
Inclusion
- Phase I - Cross-sectional Study (CD and Suspected IBD)
- Age criteria: \> 1 year to \< 22 years of age
- Diagnosis of Crohn's disease, anti-TNF naïve, and colonoscopy scheduled OR
- Clinical suspicion for IBD (treatment naïve) and colonoscopy scheduled
- Permission of parent/guardian and assent or consent of research participant
Exclusion
- Any prior treatment with an anti-TNF, such as infliximab, adalimumab, certolizumab or golimumab
- Known diagnosis of ulcerative colitis (UC) or inflammatory bowel disease-unspecified (IBD-U)
- Active or prior evidence of internal (abdominal/pelvic) penetrating fistula(e)
- Active intra-abdominal abscess or perianal abscess
- Active Clostridium difficile infection or other known enteric infection in last 2 weeks
- Current ileostomy or colostomy, extensive small bowel resection, ileoanal pouch or short bowel syndrome
- History of autoimmune disease (including autoimmune hepatitis, primary sclerosing cholangitis, thyroiditis, psoriasis or juvenile idiopathic arthritis)
- Any condition that in the opinion of the PI will prevent the research participant from taking part in this study
- Phase I - Cross-sectional Study (healthy volunteers)
- Inclusion Criteria:
- Age criteria: \> 1 year to \< 22 years of age
- Any CCHMC patient
- Permission of parent/guardian and assent or consent of research participant
Key Trial Info
Start Date :
October 16 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2023
Estimated Enrollment :
239 Patients enrolled
Trial Details
Trial ID
NCT04131504
Start Date
October 16 2019
End Date
October 31 2023
Last Update
January 30 2024
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06016
2
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229
3
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
4
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226