Welcome to ProCeDE!

ProCeDE = Prospective Celiac Disease Diagnostic Evaluation

German Registry for Clinical Trials: Reg-No DRKS00003555

 

*******************************   NEWS and PROGRESS   *******************************

May 2017: The ProCeDE results were submitted to the ESPGHAN annual Meeting and successfully presented in Prague in the Gastroenterology session.

Dec 2016: After months of re-investigating and revising the data and discussing the drafts, the main manuscript was finalized and firstly submitted for publication.

May 2015: At the annual ESPGHAN meeting in Amsterdam, the clinical centers were invited for an internal presentation of the current data

Jan 2015: The ProCeDE committee met during the ESPGHAN Coeliac Working group meeting in Munich and discussed further steps.

June 2014: The main database is now complete for the baseline data of the clinical centers. Two third of the samples are processed and analysed in the central labs. During the annual meeting of the ESPGHAN (European Society of Pediatric Gastroenterology, Hepatology and Nutrition) in Jerusalem, a ProCeDE presentation was given by Sibylle Koletzko during the Parallel Symposia: The Diagnosis of Coeliac Disease, 11th June, 16:20, Location: Teddy A.

Dec 2013: Finally more than 750 patients are already included in the study and recruitment will be finished by 31 Dec 2013. The central analysis of several CD specific antibodies, HLA-typing of DNA and histopathology review are ongoing.

Sept 2013: During the ICDS (International Celiac Disease Symposium) in Chicago, a poster about the clinical presentation at diagnosis of patients in the ProCeDE study was presented. Currently, about 650 patients have been included and another 100 patients are still being recruited. Central lab analysis are proceeding.

May 2013: During the 46th annual meeting of the European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) in London, two presentations about ProCeDE had been given: an update on the current process of the study during the Celiac Disease Working Group meeting and an oral abstract presentation about descriptive data of the ProCeDE cohort. Almost 600 patients had been recruited.

Feb 2013: Meanwhile, more than 500 patients had been recruited and the database comprises the clincial diagnosis of 400 patients.

The descriptive data of the European respectively Belgian ProCeDE cohort was presented during the Belgian Pediatric Conference.

The abstract "Clinical Spectrum of Unselected Newly Diagnosed Coeliac Disease Patients - Data from the Multi-Center Study ProCeDE" was accepted for oral presentation at the ESPGHAN conference.

Dec 2012: Already 400 patients had been recruited and the data of more than 300 patients are in the database now!

Sept 2012: ProCeDE had been presented at the AOECS meeting which was held during the  "Better life for Coeliacs" conference at Hilton Hotel Kalastajatorppa, Helsinki.

July 2012: The interim analysis with data of the first 200 patients revealed that the estimated sample size of about 600 patients is still valid to proof the main hypothesis with a high power.

June 2012: A Poster of the ProCeDE study design had been presented at the DGVS Spring Conference 2012 'Frontiers in Coeliac Disease', 8 to 9 june, Charité Berlin.

Interim analysis is in preparation. Centers are invited to submit the eCRFs.

Mai 2012: The first 200 patients had been recruited and the interim analysis to re-calculate the sample size is in preparation.

April 2012: An update on ProCeDE had been presented during the ESPGHAN-congress in Stockholm, 27 april 2012. Till the end of april, 27 centers identified about 155 eligible patients and recruited 140 children for participation. In total, 40 centers will finally be involved in ProCeDE and the recuitment of clinical centers had been closed.

March 2012: Zagreb and Porto received the approval. In total 19 centers recruited 90 patients.

Feb 2012: The centers in Bucharest, Graz, Valencia, Tampere and the Belgian cooperating centers received the approval. Currently 17 centers are recruiting and more than 50 patients had been included.

Jan 2012: The number of patients rose up to 30. Warsaw, Prague, Gent and Tabriz obtained the approval.The electronic CaseReportForm is ready for use.

Dec 2011: Reus, Athens, Tabriz, Budapest and Vienna obtained their ethical approval and the first ten patients were recruited!

Nov 2011: Munich obtained the first ethical approval, other centers are already getting started

Oct 2011: ProCeDE is online!