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Histomolecular Profiling in Small-Bowel Diseases

Recruitingn/aAges 18 Years - anyAllTampere University Hospital
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In plain words

What the trial is, and whether it could suit you

This prospective cohort study aims to establish reliable histological reference values for normal small-bowel mucosa, improve histological diagnostic quality in celiac disease, and develop an advanced molecular profile for disease diagnosis and treatment response evaluation. The study will collect duodenal biopsies from three groups: healthy controls undergoing clinically indicated gastroscopy, patients referred for primary celiac disease diagnostics, and patients with small-bowel mucosal injury unresponsive to a gluten-free diet. Patients will undergo routine clinical assessment via standard pathology review of diagnostic biopsies. Biopsies will be analyzed using digital morphometry, AI-based image analysis, RNA sequencing (transcriptomics), and intestinal organoid cultures.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ 18 years * Clinically indicated upper gastrointestinal endoscopy (gastroscopy) * Written informed consent obtained prior to procedure * For Group 1 (Healthy Controls): Negative celiac disease antibodies (anti-transglutaminase and/or anti-endomysium); no suspected celiac * For Group 2 (Celiac Diagnostics): Referred for primary celiac disease diagnostics requiring duodenal biopsy * For Group 3 (Refractory Injury): Confirmed small-bowel mucosal injury not responsive to a gluten-free diet Exclusion Criteria: * For Group 1 (Healthy Controls): Other small-bowel diseases causing mucosal injury, including Crohn's disease and small-bowel ulcers * Inability to provide written informed consent * Refusal to participate
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What it tests

  • Not listed
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Where

3 sites
Hatanpรครค Specialist Medical Care
Tampere, Finland
Tampere University Hospital (Tays)
Tampere, Finland
Valkeakoski Regional Hospital
Valkeakoski, Finland
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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