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Inflammatory Bowel Disease (IBD)CEDATA GPGENCT06606756

CEDATA GPGE - a Patient Registry for Children and Adolescents With Inflammatory Bowel Disease

An observational study of Inflammatory Bowel Disease (IBD), run by University of Giessen at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

CEDATA GPGE collects clinical data of children and adolescents with IBD from paediatric gastroenterology centers in german-speaking countries. Data is obtained from participating centers in pseudonymized way via an online platform at the beginning and during followup of the disease. Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Inflammatory Bowel Disease (IBD)
What is being tested?
Patient Registry without intervention and Digital Registry and Feedback on clinical data
How many people
6,300 participants
Where
1 siteGermany
Study dates
1 Sep 2004to 1 Dec 2034
How long will I take part?
18 Years
Phase
Observational
Are there results?
Not yet: the study is under way

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 Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: children and adolescents with IBD

Who may be able to join

  • Inflammatory Bowel Disease

Who cannot join

  • none

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jan de Laffolie, MD contact

+49 641 985 43400

jan.delaffolie@paediat.med.uni-giessen.de

Studienzentrale KIA contact

+49 641 985 43400

studienzentrale@paediat.med.uni-giessen.de

Germany1 site, 1 recruiting

  • University Giessen

    Giessen, 35392

    Jan de Laffolie, MD, +49 641 985 43400, jan.delaffolie@paediat.med.uni-giessen.de

    Jan de Laffolie, MD

    Recruiting

Other trials in Germany

About this study

Official title: CEDATA GPGE Patient Registry for Children and Adolescents With IBD

CEDATA GPGE collects clinical data of children and adolescents with IBD from paediatric gastroenterology centers in german-speaking countries.

Data is obtained from participating centers in pseudonymized way via an online platform at the beginning and during followup of the disease. The leading working group of the paediatric gastroenterology society GPGE e.V. includes 15 experts in the field who meet twice yearly and coordinate research and quality improvement initiatives.

Being tested
Patient Registry without intervention, Digital Registry and Feedback on clinical data
Keywords
paediatric, crohns disease, ulcerative colitis, quality improvement, patient registry
Medical subject headings
Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient Registry without interventionOther

    This is a patient registry that collects real world data without intervening with therapeutic decision

  • Digital Registry and Feedback on clinical dataOther

    The data is entered via a validated online platform and is provided back to the center in aggregated form

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Remission

    Clinical Remission - absence of symptoms

    Measured: any

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2024
  2. Study start1 Sep 2004
  3. Primary completion1 Dec 2034 (estimated)
  4. Study completion1 Dec 2034 (estimated)

Resources

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
Other
Time perspective
Prospective
Enrolment
6,300 participants (estimated)
Target duration
18 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06606756
Sponsor's protocol ID
CEDATA GPGE
Acronym
CEDATA GPGE
Status last verified
Sep 2024
First submitted
4 Sep 2024
Last updated
23 Sep 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • de Laffolie J, Koletzko S, Buderus S, Classen M, Posovszky C, Rodeck B, Keller KM, Lang T, Hauer A; CEDATA GPGE Study Group. Lack of Correlation of Mean Corpuscular Volume to White Blood Cell Ratio to Thiopurine Levels. J Pediatr Gastroenterol Nutr. 2020 May;70(5):e107-e110. doi: 10.1097/MPG.0000000000002662. No abstract available.

    PubMed 32079979

  • Kern I, Schoffer O, Richter T, Kiess W, Flemming G, Winkler U, Quietzsch J, Wenzel O, Zurek M, Manuwald U, Hegewald J, Li S, Weidner J, de Laffolie J, Zimmer KP, Kugler J, Laass MW, Rothe U. Current and projected incidence trends of pediatric-onset inflammatory bowel disease in Germany based on the Saxon Pediatric IBD Registry 2000-2014 -a 15-year evaluation of trends. PLoS One. 2022 Sep 9;17(9):e0274117. doi: 10.1371/journal.pone.0274117. eCollection 2022.

    PubMed 36084003

  • Kern I, Schoffer O, Kiess W, Henker J, Laass MW, Winkler U, Quietzsch J, Wenzel O, Zurek M, Buttner K, Fischer P, de Laffolie J, Manuwald U, Stange T, Zenker R, Weidner J, Zimmer KP, Kunath H, Kugler J, Richter T, Rothe U. Incidence trends of pediatric onset inflammatory bowel disease in the years 2000-2009 in Saxony, Germany-first results of the Saxon Pediatric IBD Registry. PLoS One. 2021 Jan 4;16(1):e0243774. doi: 10.1371/journal.pone.0243774. eCollection 2021.

    PubMed 33395450

  • Schiller B, Wirthgen E, Weber F, Schiller S, Radke M, Classen M, Dabritz J; CEDATA-GPGE Study Group. Fecal calprotectin and platelet count predict histologic disease activity in pediatric ulcerative colitis: results from a projection-predictive feature selection. Eur J Pediatr. 2024 Aug;183(8):3277-3288. doi: 10.1007/s00431-024-05554-y. Epub 2024 May 6.

    PubMed 38709314

  • de Laffolie J, Zimmer KP, Sohrabi K, Hauer AC. Running Behind "POPO"-Impact of Predictors of Poor Outcome for Treatment Stratification in Pediatric Crohn's Disease. Front Med (Lausanne). 2021 Aug 27;8:644003. doi: 10.3389/fmed.2021.644003. eCollection 2021.

    PubMed 34513855

  • Tischler L, Boerkoel A, Krause H, van den Berg N, de Laffolie J. The Care of Children and Adolescents with Chronic Inflammatory Bowel Disease: A Cluster-Randomized Trial on Improving the Guideline Conformity of Treatment by the Use of the CEDATA-GPGE Patient Registry. Dtsch Arztebl Int. 2024 Sep 20;121(19):627-633. doi: 10.3238/arztebl.m2024.0168.

    PubMed 39163213

  • de Laffolie J, Laass MW, Scholz D, Zimmer KP, Buderus S; CEDATA-GPGE Study Group. Prevalence of Anemia in Pediatric IBD Patients and Impact on Disease Severity: Results of the Pediatric IBD-Registry CEDATA-GPGE(R). Gastroenterol Res Pract. 2017;2017:8424628. doi: 10.1155/2017/8424628. Epub 2017 Dec 5.

    PubMed 29358946

  • de Laffolie J, Schwerd T, Simon A, Pauli M, Broekaert I, Classen M, Posovszky C, Schmidt-Choudhury A; im Namen und Auftrag der AGs CEDATA und AG Ernahrung und Diatetik/Ernahrungsmedizin der GPGE. [Crohn's Disease Exclusion Diet - an alternative to exlusive enteral nutritional therapy in children and adolescents with Crohn's disease? Statement of the GPGE working groups CEDATA and Nutrition/Nutrition Medicine]. Z Gastroenterol. 2020 Sep;58(9):890-894. doi: 10.1055/a-1199-6751. Epub 2020 Sep 18. German.

    PubMed 32947634

  • Buderus S, Scholz D, Behrens R, Classen M, De Laffolie J, Keller KM, Zimmer KP, Koletzko S; CEDATA-GPGE Study Group. Inflammatory bowel disease in pediatric patients: Characteristics of newly diagnosed patients from the CEDATA-GPGE Registry. Dtsch Arztebl Int. 2015 Feb 20;112(8):121-7. doi: 10.3238/arztebl.2015.0121.

    PubMed 25759978

  • Bruckner A, Werkstetter KJ, de Laffolie J, Wendt C, Prell C, Weidenhausen T, Zimmer KP, Koletzko S; CEDATA-GPGE study group. Incidence and Risk Factors for Perianal Disease in Pediatric Crohn Disease Patients Followed in CEDATA-GPGE Registry. J Pediatr Gastroenterol Nutr. 2018 Jan;66(1):73-78. doi: 10.1097/MPG.0000000000001649.

    PubMed 28604511

  • Leiz M, Knorr M, Moon K, Tischler L, Sohrabi K, Cantez S, Dabritz J, de Laffolie J, van den Berg N; CEDATA GPGE Study Group. How can patient registries facilitate guideline-based healthcare? A retrospective analysis of the CEDATA-GPGE registry for pediatric inflammatory bowel disease. BMC Health Serv Res. 2023 Jun 17;23(1):648. doi: 10.1186/s12913-023-09639-6.

    PubMed 37330476

  • Schneider N, Sohrabi K, Schneider H, Zimmer KP, Fischer P, de Laffolie J; CEDATA-GPGE Study Group. Machine Learning Classification of Inflammatory Bowel Disease in Children Based on a Large Real-World Pediatric Cohort CEDATA-GPGE(R) Registry. Front Med (Lausanne). 2021 May 24;8:666190. doi: 10.3389/fmed.2021.666190. eCollection 2021.

    PubMed 34109197

  • Peters S, Cantez S, De Laffolie J; CEDATA Study Group. Implementation of exclusive enteral nutrition in pediatric patients with Crohn's disease-results of a survey of CEDATA-GPGE reporting centers. Mol Cell Pediatr. 2022 Apr 5;9(1):6. doi: 10.1186/s40348-022-00139-x.

    PubMed 35381916

  • Classen M, de Laffolie J, Classen M, Schnell A, Sohrabi K, Hoerning A. Significant advantages for first line treatment with TNF-alpha inhibitors in pediatric patients with inflammatory bowel disease - Data from the multicenter CEDATA-GPGE registry study. Front Pediatr. 2022 Jul 19;10:903677. doi: 10.3389/fped.2022.903677. eCollection 2022.

    PubMed 36304532

  • Laffolie J, Zimmer KP, Sohrabi K, Hauer AC. Early Immune Suppression in Children and Adolescents With Crohn's Disease-Data From the CEDATA GPGE Registry. Dtsch Arztebl Int. 2021 Jun 18;118(24):421-422. doi: 10.3238/arztebl.m2021.0214. No abstract available.

    PubMed 34369371

Questions about this trial

What is this clinical trial studying?

An observational study of Inflammatory Bowel Disease (IBD), run by University of Giessen at 1 site in Germany.

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: looking for participants now, as of the sponsor's last update on 23 Sep 2024. 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 Germany. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jan de Laffolie, MD (+49 641 985 43400, jan.delaffolie@paediat.med.uni-giessen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Remission (time frame: any). 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 NCT06606756, which also lists 19 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 23 Sep 2024.

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