Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-30 @ 11:37 AM
Study NCT ID:
NCT01041469
Status:
COMPLETED
Last Update Posted:
2012-03-22
First Post:
2009-12-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study of Auto-immune Abnormalities Associated With Down Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004314', 'term': 'Down Syndrome'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}], 'ancestors': [{'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood and white cells'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-21', 'studyFirstSubmitDate': '2009-12-30', 'studyFirstSubmitQcDate': '2009-12-30', 'lastUpdatePostDateStruct': {'date': '2012-03-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Auto-antibodies dosage', 'timeFrame': 'at enrolment'}, {'measure': 'specific lymphocytes populations count', 'timeFrame': 'at enrolment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Down syndrome, Humans,Clinical study,Immunity, Autoimmunity,'], 'conditions': ['Down Syndrome With and Without Auto Immune Abnormalities']}, 'referencesModule': {'references': [{'pmid': '2528336', 'type': 'BACKGROUND', 'citation': "Friedman DL, Kastner T, Pond WS, O'Brien DR. Thyroid dysfunction in individuals with Down syndrome. Arch Intern Med. 1989 Sep;149(9):1990-3."}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to identify biological data linked to auto immune abnormalities associated with Down Syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '36 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Down syndrome patients followed in a specialized clinic devoted to healthcare of mentally retarded children and adults', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Free and complete trisomy 21\n* aged between 8 and 36 years\n* biological or clinical signs of auto-immune disorder (group 1)\n* no sign of auto-immune disorder (group 2)\n\nExclusion Criteria:\n\n* any antimitotic or immune depressing treatment during the last 6 months\n* Current infectious disease\n* Corticosteroid therapy in the last 3 weeks\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT01041469', 'acronym': 'IMMUTRI', 'briefTitle': 'Pilot Study of Auto-immune Abnormalities Associated With Down Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Institut Jerome Lejeune'}, 'officialTitle': 'Pilot Study of Auto-immune Abnormalities Associated With Down Syndrome', 'orgStudyIdInfo': {'id': 'IJL-IMM-EP10'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'with abnormalities', 'description': 'Down syndrome patients presenting with at least one sign of auto immune abnormality'}, {'label': 'without abnormality', 'description': 'Down syndrome patients without any sign of recognized auto immune condition'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Jerome Lejeune', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75743', 'city': 'Paris', 'country': 'France', 'facility': "Laboratoire d'Immunologie Biologique (Unité INSERM U580)", 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Jerome Lejeune', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondation Jérôme Lejeune', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}