Description of Disease Course, Disease Fenotype, Medication, Safety, Analysis for Possible AssociationsBelcroNCT01241058
Registry of Pediatric Patients Diagnosed With Crohn's Disease in Belgium
An observational study of Description of Disease Course, Disease Fenotype, Medication, Safety, Analysis for Possible Associations, run by Gigi Veereman at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Description of Disease Course, Disease Fenotype, Medication, Safety, Analysis for Possible Associations
- How many people
- 257 participants
- Where
- 1 siteBelgium
- Study dates
- May 2008to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: subjects under 18 yrs of age diagnosed with Crohn's disease, living in Belgium
Who may be able to join
- 1-18 yrs old belgian Crohn s disease informed consent
Who cannot join
- no informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Belgian Registry of Pediatric Crohn's Disease
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.
- Keywords
- pediatrics, crohn's disease, disease course, therapy
- Medical subject headings
- Crohn Disease, Disease Progression
What is being measured
The primary outcome is the main question the study is designed to answer.
disease course
describe patient characteristics, disease fenotype and course
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startMay 2008
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Description of Disease Course, Disease Fenotype, Medication, Safety, Analysis for Possible AssociationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gigi Veereman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gigi Veereman, Belgian Society for Pediatric Gastroentrology Hepatology and Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01241058
- Sponsor's protocol ID
- Bespghan
- Acronym
- Belcro
- Status last verified
- Jan 2016
- First submitted
- 15 Nov 2010
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25354967De Greef E, Maus B, Smets F, Van Biervliet S, John JM, Van Steen K, Veereman G; IBD working group of the Belgian Society of Pediatric Gastroenterology, Hepatology and Nutrition (BeSPGHAN); Belgian IBD Research and Development (BIRD). Diagnosing and treating pediatric Crohn's disease patients: is there a difference between adult and pediatric gastroenterologist's practices ? Results of the BELCRO cohort. Acta Gastroenterol Belg. 2014 Mar;77(1):25-9. No abstract available.
PubMed 24761688De Greef E, Mahachie John JM, Hoffman I, Smets F, Van Biervliet S, Scaillon M, Hauser B, Paquot I, Alliet P, Arts W, Dewit O, Peeters H, Baert F, D'Haens G, Rahier JF, Etienne I, Bauraind O, Van Gossum A, Vermeire S, Fontaine F, Muls V, Louis E, Van de Mierop F, Coche JC, Van Steen K, Veereman G; IBD working group of the Belgian Society of Pediatric Gastroenterology, Hepatology and Nutrition (BeSPGHAN); Belgian IBD Research and Development. Profile of pediatric Crohn's disease in Belgium. J Crohns Colitis. 2013 Dec;7(11):e588-98. doi: 10.1016/j.crohns.2013.04.016. Epub 2013 May 9.
PubMed 23664896Alliet P, Desimpelaere J, Hauser B, Janssens E, Khamis J, Lewin M, De Greef E, Smets F, Paquot I, Veereman G, Souverijns G; Belgian IBD working group of BeSPGHAN. MR enterography in children with Crohn disease: results from the Belgian pediatric Crohn registry (Belcro). Acta Gastroenterol Belg. 2013 Mar;76(1):45-8.
PubMed 23650782De Greef E, Hoffman I, Smets F, Van Biervliet S, Bontems P, Hauser B, Paquot I, Alliet P, Arts W, Dewit O, De Vos M, Baert F, Bossuyt P, Rahier JF, Franchimont D, Vermeire S, Fontaine F, Louis E, Coche JC, Veereman G; IBD working group of BESPGHAN, BIRD. Paediatric Crohn Disease: Disease Activity and Growth in the BELCRO Cohort After 3 Years Follow-up. J Pediatr Gastroenterol Nutr. 2016 Aug;63(2):253-8. doi: 10.1097/MPG.0000000000001132.
PubMed 26835906
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Belgian Registry of Pediatric Crohn's Disease
- ClinicalTrials.gov ID
- NCT01241058
- Acronym / sponsor ID
- Belcro / Bespghan
- Keywords
- pediatrics, crohn's disease, disease course, therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Gigi VeeremanUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 16 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- subjects under 18 yrs of age diagnosed with Crohn's disease, living in Belgium
Key inclusion criteria (1 listed)
- 1-18 yrs old belgian Crohn s disease informed consent
Key exclusion criteria (1 listed)
- no informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
disease course
Time frame: 5 years
describe patient characteristics, disease fenotype and course
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
- Results publication: PubMed 25354967Van 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.
- Results publication: PubMed 24761688De Greef E, Maus B, Smets F, Van Biervliet S, John JM, Van Steen K, Veereman G; IBD working group of the Belgian Society of Pediatric Gastroenterology, Hepatology and Nutrition (BeSPGHAN); Belgian IBD Research and Development (BIRD). Diagnosing and treating pediatric Crohn's disease patients: is there a difference between adult and pediatric gastroenterologist's practices ? Results of the BELCRO cohort. Acta Gastroenterol Belg. 2014 Mar;77(1):25-9. No abstract available.
- Results publication: PubMed 23664896De Greef E, Mahachie John JM, Hoffman I, Smets F, Van Biervliet S, Scaillon M, Hauser B, Paquot I, Alliet P, Arts W, Dewit O, Peeters H, Baert F, D'Haens G, Rahier JF, Etienne I, Bauraind O, Van Gossum A, Vermeire S, Fontaine F, Muls V, Louis E, Van de Mierop F, Coche JC, Van Steen K, Veereman G; IBD working group of the Belgian Society of Pediatric Gastroenterology, Hepatology and Nutrition (BeSPGHAN); Belgian IBD Research and Development. Profile of pediatric Crohn's disease in Belgium. J Crohns Colitis. 2013 Dec;7(11):e588-98. doi: 10.1016/j.crohns.2013.04.016. Epub 2013 May 9.
- Results publication: PubMed 23650782Alliet P, Desimpelaere J, Hauser B, Janssens E, Khamis J, Lewin M, De Greef E, Smets F, Paquot I, Veereman G, Souverijns G; Belgian IBD working group of BeSPGHAN. MR enterography in children with Crohn disease: results from the Belgian pediatric Crohn registry (Belcro). Acta Gastroenterol Belg. 2013 Mar;76(1):45-8.
- Derived from this study: PubMed 26835906De Greef E, Hoffman I, Smets F, Van Biervliet S, Bontems P, Hauser B, Paquot I, Alliet P, Arts W, Dewit O, De Vos M, Baert F, Bossuyt P, Rahier JF, Franchimont D, Vermeire S, Fontaine F, Louis E, Coche JC, Veereman G; IBD working group of BESPGHAN, BIRD. Paediatric Crohn Disease: Disease Activity and Growth in the BELCRO Cohort After 3 Years Follow-up. J Pediatr Gastroenterol Nutr. 2016 Aug;63(2):253-8. doi: 10.1097/MPG.0000000000001132.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Description of Disease Course, Disease Fenotype, Medication, Safety, Analysis for Possible Associations, run by Gigi Veereman at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease course (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01241058, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2016.