"Adding DNA-test for Screening of HLA-DQ2 and DQ8 to Improve Early Diagnosis of Celiac Disease"

Enrolling by invitationOBSERVATIONAL
Enrollment

508

Participants

Timeline

Start Date

September 1, 2022

Primary Completion Date

May 1, 2024

Study Completion Date

November 1, 2024

Conditions
Celiac Disease in Children
Interventions
OTHER

DNA test for screening HLA-DQ2 and DQ8 from dried blood spots to early detect Celiac Disease

Phase 1 and 2: After blood collection (in combination with regular care) and informed consent, a blood droplet obtained by an additional fingerprick (Phase 1 and just an extra droplet from an existing finger prick for Phase 2) will be deposited on filter paper S\&S 903™ (Schleicher and Schuell). DNA will be isolated using the QIAamp method designated for this purpose from dried blood spots (Qiagen). The results of the HLA-DQ2 and DQ8-typing using the dried blood spots will be compared with the results of the traditional HLA-typing. Factors that may influence the quality of the material will be taken into account in the validation process.

Trial Locations (1)

2333 ZA

Leiden University Medical Centre (LUMC), Leiden

All Listed Sponsors
collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

lead

Leiden University Medical Center

OTHER