Improved laboratory diagnostics for celiac disease.
- Conditions
- celiac diseasegluten intolerance10017969
- Registration Number
- NL-OMON54772
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 90
- >= 18 years old
- Indication for a duodenal biopsy for the diagnosis or monitoring of:
active celiac disease, celiac disease on gluten free diet, suspicion
celiac disease, dyspeptia, potential celiac disease OR previously diagnosed
with celiac disease, dyspepsia or NCGS without an indication for duodenum biopsy
- Given informed consent
- HLA-DQ2.5 positive (in exceptional cases where endoscopic examination is
already performed before HLA typing and the patient turns out to be HLA-DQ2.5
negative, the γδT-cell data can be used for analysis.
- No informed consent
- Insufficient knowledge of Dutch language and/or inability to understand the
information provided.
- Systemic immune suppressive treatment for the past 3 months,
- pregnancy (not applicable to groups 2b and 4b)
- HIV, Hepatitis B or C positive status
- Severe disorders within the last 6 months, e.g. cancer
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1) Detection method for gliadin specific T-cells in peripheral blood<br /><br>2) Determine celiac disease associated duodenal γδT-cell phenotype<br /><br>3) Detection of γδT-cells with *CD-related phenotype* in peripheral blood<br /><br>4) Sensitivity and specificity of cellular blood test (gliadin specific T-cells<br /><br>and γδT-cells with *CD-related phenotype) for diagnosis of CD in patients on a<br /><br>gluten containing or GFD in a routine specialized diagnostic setting.<br /><br>5) Sensitivity and specificity of cellular blood test (gliadin specific T-cells<br /><br>and γδT-cells with *CD-related phenotype) for diagnosis of CD in CD patients<br /><br>that take a personalised glutenchallenge in a routine specialized diagnostic<br /><br>setting.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Not Applicable</p><br>