Growth Relapse and Outcomes With Therapy 1

NCT00711945 | Completed DMC

• 1 other identifier: GROWTH1
• Study Type: observational
• Target: 348
• Locations: 1 country
• Sites: 1

Brief Summary

Pediatric Crohn's Disease is a life long disease , presenting early in life.As such , it is imperative to be able to evaluate the risk for more severe disease and poorer outcomes when making the decision which therapies to offer our patients. These decisions should be based according to longer-term disease outcomes, such as whether they prevent disease relapse or prolong remission \[10-12\]. However, for the most part, previous studies were not designed to yield predictive parameters that could allow a clinician to differentiate which patients are at a higher risk for relapse, or more likely to to have serious attacks or complications of the disease or therapy. The ability to predict these risks would impact dramatically the way CD patients are treated, allowing the clinician to tailor therapy, both type and intensity, to each patient's individual risk for relapse and outcomes.In the present first phase of the study , we will attempt to identify factors that predict relapse of the disease, focusing on the use of calprotectin at onset and after clinical remission, and on the use of anti-glycan antibodies, as well as disease severity, site and phenotype.

Conditions

Crohn's Disease; Pediatric Onset

Keywords

Crohn's disease; Relapse; outcomes; growth

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

New onset pediatric Crohn's disease until and including age 18

You may qualify if:

• Age 0-18
• New onset Crohn's disease
• Treatment naive
• Ileocolonoscopy +radiology

You may not qualify if:

• Prior Treatment

Sponsors & Collaborators

• European Society of Pediatric Gastroenterology, Hepatology and Nutrition: lead

Study Sites (1)

Wolfson Medical center

Holon, 58100, Israel

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum for antiglycan antibodies stool for calprotectin

MeSH Terms

Conditions

Crohn Disease; Recurrence

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 7, 2008
• First Posted: July 9, 2008
• Study Start: March 1, 2008
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 2, 2018

Record last verified: 2018-08

Locations

IL (1)