Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-01-02 @ 4:55 AM
Study NCT ID:
NCT05597904
Status:
RECRUITING
Last Update Posted:
2025-09-17
First Post:
2022-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Background of Different Phenotypes of Coeliac Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002446', 'term': 'Celiac Disease'}, {'id': 'D003874', 'term': 'Dermatitis Herpetiformis'}], 'ancestors': [{'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012872', 'term': 'Skin Diseases, Vesiculobullous'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005820', 'term': 'Genetic Testing'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D033142', 'term': 'Genetic Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D003954', 'term': 'Diagnostic Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-10', 'studyFirstSubmitDate': '2022-10-03', 'studyFirstSubmitQcDate': '2022-10-25', 'lastUpdatePostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Non-HLA variant association', 'timeFrame': 'baseline', 'description': 'phenotype specific non-HLA variants'}], 'secondaryOutcomes': [{'measure': 'serum transglutaminase antibodies', 'timeFrame': 'baseline', 'description': 'Levels of serum antibodies against transglutaminase'}, {'measure': 'microbiata', 'timeFrame': 'baseline', 'description': 'skin and intestinal microbiata findings'}, {'measure': 'quality of life measure', 'timeFrame': 'baseline', 'description': 'PGWB questionnaire (22-items with values 1-6, total score range 22-132, a higher score indicating better quality of life)'}, {'measure': 'gastrointestinal symptoms', 'timeFrame': 'baseline', 'description': 'GSRS-questionnaire (15 items with values 1-7, total score 1-7 as a mean value of all scores, higher score indicating more severe symptoms)'}, {'measure': 'dietary adherence', 'timeFrame': 'baseline', 'description': 'strictness of gluten-free diet (GIP-test)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['coeliac disease', 'dermatitis herpetiformis', 'gluten-free diet', 'transglutaminase', 'microbiata'], 'conditions': ['Celiac Disease', 'Dermatitis Herpetiformis']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to investigate genetic, serological, immunological and microbiata diversities between different coeliac disease phenotypes and to discover applicable prognostic markers for specific phenotypes.', 'detailedDescription': 'The recognition of clinical heterogeneity has expanded the understanding of coeliac disease, but the factors contributing to this diversity remain unclear. Moreover, since coeliac disease is highly heterogeneous, there is a need for more individualized follow-up and support and implementation of more personalized follow-up guidelines.\n\nIn this study coeliac disease and dermatitis herpetiformis patients and healthy controls will be recruited. Genetic, clinical, immunological, micobiata and novel biomedical markers are compared between coeliac disease phenotypes and also controls and their prognostic value is assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'National and also focused recruitment for patients with coeliac disease or dermatitis herpetiformis diagnosis. Healthy controls recruited via volunteered subjects with coeliac disease or dermatitis herpetiformis', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cohorts 1 and 2: coeliac disease or dermatitis herpetiformis diagnosis\n* Cohort 3: friend or non-related family member of coeliac disease or dermatitis herpetiformis patient\n\nExclusion Criteria:\n\n* Cohorts 1-3: Age \\<18 years\n* Cohorts 1 and 2: coeliac disease or dermatitis herpetiformis diagnosis not confirmed\n* Cohort 3: coeliac disease or dermatitis herpetiformis diagnosis'}, 'identificationModule': {'nctId': 'NCT05597904', 'briefTitle': 'Background of Different Phenotypes of Coeliac Disease', 'organization': {'class': 'OTHER', 'fullName': 'Tampere University Hospital'}, 'officialTitle': 'Genetic and Biological Background and Follow-up of Different Phenotypes of Coeliac Disease', 'orgStudyIdInfo': {'id': 'R22088'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Coeliac disease patients', 'description': 'Adult (18 years or over) patients with previous coeliac disease or dermatitis herpetiformis diagnosis', 'interventionNames': ['Genetic: Genetic predisposition']}, {'label': 'Healthy controls', 'description': '500 adult (18 years or over) friends or non-related family members of coeliac disease or dermatitis herpetiformis patients participating in the study, no previous coeliac disease or dermatitis herpetiformis diagnosis. In addition 1000 controls will be included from Biobank', 'interventionNames': ['Genetic: Genetic predisposition']}], 'interventions': [{'name': 'Genetic predisposition', 'type': 'GENETIC', 'description': 'Assessment of genetic predisposition to various celiac disease phenotypes. No intervention.', 'armGroupLabels': ['Coeliac disease patients', 'Healthy controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33521', 'city': 'Tampere', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Teea T Salmi, Prof', 'role': 'CONTACT', 'email': 'teea.salmi@tuni.fi', 'phone': '+358 503016355'}, {'name': 'Teea T Salmi, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}], 'centralContacts': [{'name': 'Teea T Salmi, Prof', 'role': 'CONTACT', 'email': 'teea.salmi@pshp.fi', 'phone': '+358503016355'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tampere University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tampere University', 'class': 'OTHER'}, {'name': 'University of Helsinki', 'class': 'OTHER'}, {'name': 'University of Turku', 'class': 'OTHER'}, {'name': 'Oulu University Hospital', 'class': 'OTHER'}, {'name': 'University of Debrecen', 'class': 'OTHER'}, {'name': 'University of Trieste', 'class': 'OTHER'}, {'name': 'Oslo University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor in Dermatology', 'investigatorFullName': 'Teea Salmi', 'investigatorAffiliation': 'Tampere University Hospital'}}}}