Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2026-03-22 @ 12:04 PM
Study NCT ID:
NCT04462068
Status:
COMPLETED
Last Update Posted:
2024-01-25
First Post:
2020-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ACE and HLA Genotypes Predict Severity and Disease Progression in Danish Sarcoid Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012507', 'term': 'Sarcoidosis'}], 'ancestors': [{'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006968', 'term': 'Hypersensitivity, Delayed'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-24', 'studyFirstSubmitDate': '2020-05-11', 'studyFirstSubmitQcDate': '2020-07-03', 'lastUpdatePostDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to initiation of treatment', 'timeFrame': '1 year from diagnosis', 'description': 'Time to initiation of systemic immunosuppression for sarcoidosis'}], 'secondaryOutcomes': [{'measure': 'Number of participants with extrapulmonary organ involvement', 'timeFrame': '1 year from diagnosis', 'description': 'Number of participants diagnosed with extrapulmonary organ involvement'}, {'measure': 'Change in FEV1', 'timeFrame': '1 year', 'description': 'Increase/ decline/ no change in FEV1'}, {'measure': 'Change in FVC', 'timeFrame': '1 year', 'description': 'Increase/ decline/ no change in FVC'}, {'measure': 'Change in diffusion capacity', 'timeFrame': '1 year', 'description': 'Increase/ decline/ no change in diffusion capacity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sarcoidosis']}, 'descriptionModule': {'briefSummary': 'Sarcoidosis is a multisystem granulomatous disease of unknown cause histologically characterized by noncaseating granulomas. Genetic factors affect disease course, which is highly variable and difficult to predict.\n\nThis study aims to evaluate the predictive value of ACE and HLA genotypes on disease severity and progression in Danish patients with sarcoidosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with sarcoidosis seen in Department of Respiratory Diseases, Aarhus Denmark', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of sarcoidosis\n* Signed informed consent\n\nExclusion Criteria:\n\n* Inability or unwillingness to adhere to the study\n* Inability to give informed consent'}, 'identificationModule': {'nctId': 'NCT04462068', 'briefTitle': 'ACE and HLA Genotypes Predict Severity and Disease Progression in Danish Sarcoid Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'ACE and HLA Genotypes Predict Severity and Disease Progression in Danish Sarcoid Patients', 'orgStudyIdInfo': {'id': 'SAR3'}}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus N', 'country': 'Denmark', 'facility': 'Aarhus University Hospital. Dep. of Respiatory Diseases and Allergology', 'geoPoint': {'lat': 56.20367, 'lon': 10.17317}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}