Professor Steffen Husby H.C. Andersens Children's Hospital, Odense University Hospital
Projektet i tal
OPEN undersøgelse/kliniske data
Forventet # af deltagere
Inkluderet antal deltagere
Inkluderede deltagere med prøver
ProCEDE Prospective evaluation of Celiac Disease Diagnosis
The aim of this project is to investigate the effect of the new (2012) ESPGHAN (European Society for Pediatric Gastroenterology, Hepatology, and Nutrition) diagnostic criteria for Celiac Disease (CD) in a range of European countries. The principal investigator is Professor Sibylle Koletzko from Munich, Germany, with Steffen Husby as co-investigator
The project is executed as a prospective multicenter observational study, which includes 800 children and adolescents, among these 30-35 Danish patients 0-17 (incl.) years of age, with suspected CD, the children will be diagnosed based on serology and duodenal biopsies. There will be performed extensive serology, HLA testing and standard symptom assessment. The children will be followed for a period of 18 months after diagnosis. Against this background, it is evaluated whether the omission of duodenal biopsy in selected children and adolescents will lead to a safe diagnosis of CD(excluding false-positive diagnosis of CD). For further information go to the ProCeDE website.
Data and biological material
Duodenal-biopsies are taken in conjunction with endoscopy, with 4 biopsies distally to the papilla of Vater from duodenums second piece and 2 from the duodenal bulb, the best-oriented biopsy is sent for central pathology at Anatomia Patologica II, Brescia, Italy. Blood samples are drawn for diagnosis and clinical follow-up; these are analyzed locally for TG2, EMA, total IgA, GPT, albumin, CBC. There will also be drawn blood for project purposes, these samples will be sent to the project's central laboratory at the Department of Clinical Immunology, Odense University Hospital, at the end of the inclusion period. Here they will be analyzed for: TG2, DGP and EMA and HLA DQ2 / 8. The project will set up a biobank in collaboration with OPEN, the biobank will partly contain the Danish and partly anonymous foreign blood samples from the whole cohort. The purpose of the biobank is to complete the necessary analyzes but also in connection with the completion of the project the material will be stored for a 20-year period in an anonymous form by OPEN for further study.
Standard questionnaires will be filled out regarding clinical symptoms and adherence to gluten-free diet (GFD), physical examination with anthropometry will be executed.
Collaborating researchers and departments
Department of Clinical Immunology, Odense University Hospital