Registry of Pediatric Patients Diagnosed With Crohn's Dis... | NCT01241058

Studies
Registry of Pediatric Patients Diagnosed With Crohn's Disease in Belgium

NCT01241058

Sponsor

Gigi Veereman

Status

Completed

Last Update Posted

Jan 20, 2016Estimated

Enrollment

257Actual

Phase

Not provided

Conditions

Description of Disease Course, Disease Fenotype, Medication, Safety, Analysis for Possible Associations

Interventions

Not provided

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Apr 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Nov 15, 2010

First Submission Date that Met QC Criteria

Nov 15, 2010

First Posted Date

Nov 16, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 17, 2016

Last Update Posted Date

Jan 20, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gigi Veereman, MD PHD Pediatric Gastroenterologist, Belgian Society for Pediatric Gastroentrology Hepatology and NutritionSponsor-Investigator

Lead Sponsor

Gigi VeeremanOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A registry of pediatric patients (under 18 yrs of age) diagnosed with Crohn's disease was created in Belgium. Over a 2 year period 257 patients are included. These patients will be follow up prospectively during 5 years. Demographic data, family history, disease presentation and disease course including medication are registered in CRF's.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

257Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
disease course	describe patient characteristics, disease fenotype and course	5 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1-18 yrs old belgian Crohn s disease informed consent

Exclusion Criteria:

no informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

subjects under 18 yrs of age diagnosed with Crohn's disease, living in Belgium

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bespghan		Leuven	Brabant	3000	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25354967	Result	Van Biervliet S, Smets F, Hofmann I, Degreef E, Hauser B, Bontems P, Vande Velde S, Arts W, Paquot I, Alliet P, Bossuyt P, Louis E, Baert F, Bauraind O, Rahier JF, Veereman G. The course of anaemia in children and adolescents with Crohn's disease included in a prospective registry. Int J Colorectal Dis. 2015 Jan;30(1):51-6. doi: 10.1007/s00384-014-2042-4. Epub 2014 Oct 30.
24761688

ID	Term
D003424	Crohn Disease
D018450	Disease Progression

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases