Growth Relapse and Outcomes With Therapy 1 (GROWTH1)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2008 by European Society of Pediatric Gastroenterology, Hepatology and Nutrition.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
European Society of Pediatric Gastroenterology, Hepatology and Nutrition
ClinicalTrials.gov Identifier:
NCT00711945
First received: July 7, 2008
Last updated: July 8, 2008
Last verified: July 2008
  Purpose

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.


Condition
Crohn's Disease
Pediatric Onset

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Growth Relapse and Outcomes With Therapy 1:Factors Determining Poor Outcomes in Pediatric Crohn"s Disease

Resource links provided by NLM:


Further study details as provided by European Society of Pediatric Gastroenterology, Hepatology and Nutrition:

Biospecimen Retention:   Samples Without DNA

Serum for antiglycan antibodies stool for calprotectin


Estimated Enrollment: 300
Study Start Date: March 2008
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Prior Treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00711945

Locations
Israel
Wolfson Medical center Recruiting
Holon, Israel, 58100
Contact: Arie Levine    97235028808    alevine@wolfson.health.gov.il   
Sponsors and Collaborators
European Society of Pediatric Gastroenterology, Hepatology and Nutrition
  More Information

No publications provided

Responsible Party: Arie Levine, IBD Working Group, ESPGHAN
ClinicalTrials.gov Identifier: NCT00711945     History of Changes
Other Study ID Numbers: GROWTH1
Study First Received: July 7, 2008
Last Updated: July 8, 2008
Health Authority: Israel: Ministry of Health
Finland: Ethics Committee
Israel: Ethics Commission

Keywords provided by European Society of Pediatric Gastroenterology, Hepatology and Nutrition:
Crohn's disease
Relapse
outcomes
growth

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on July 23, 2014