Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2026-03-03 @ 12:09 PM
Study NCT ID:
NCT03366506
Status:
RECRUITING
Last Update Posted:
2021-02-10
First Post:
2017-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Epidemiological Factors Associated With the Development of Amyotrophic Lateral Sclerosis (ALS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2050-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-09', 'studyFirstSubmitDate': '2017-12-04', 'studyFirstSubmitQcDate': '2017-12-04', 'lastUpdatePostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2049-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression rate', 'timeFrame': 'up to 10 years', 'description': 'Progression of ALSFRS-R score over time'}], 'secondaryOutcomes': [{'measure': 'Appearance of clinical features of UMN or LMN dysfunction', 'timeFrame': '10 years', 'description': 'Appearance of clinical features of UMN or LMN dysfunction over time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ALS']}, 'descriptionModule': {'briefSummary': 'Investigation of the epidemiological factors associated with amyotrophic lateral sclerosis (ALS) in Israel with a view to future international collaboration. Particularly addressing:-\n\n1. Differences between ethnic subgroups\n2. Differences between immigrant and native-born populations\n3. Differences according to military service profile Clinical features gathered at each routine visit ,throughout the entire course of the disease, will be recorded in database format, in order to correlate with potential epidemiological factors.', 'detailedDescription': 'Investigation of the epidemiological factors associated with amyotrophic lateral sclerosis (ALS) in Israel with a view to future international collaboration. Particularly addressing:-\n\n1. Differences between ethnic subgroups\n2. Differences between immigrant and native-born populations\n3. Differences according to military service profile Clinical features gathered at each routine visit ,throughout the entire course of the disease, will be recorded in database format, in order to correlate with potential epidemiological factors.\n\nThe clinical features will include pattern of onset, details of full clinical exam ( including ALSFRS-R score, power, reflexes, and other signs of upper or lower-motor neuron dysfunction.\n\nCorrelations between different clinical parameters themselves will be made, as well as correlation between clinical parameters and other epidemiological factors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Population referred to ALS clinic with suspected, possible, probable ,definite ALS', 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Suspected, possible, probable ,definite ALS\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03366506', 'acronym': 'EpidALS', 'briefTitle': 'Investigation of the Epidemiological Factors Associated With the Development of Amyotrophic Lateral Sclerosis (ALS)', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'Investigation of the Epidemiological Factors Associated With the Development of Amyotrophic Lateral Sclerosis (ALS)', 'orgStudyIdInfo': {'id': '0633-08-HMO-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ALS patients', 'description': 'ALS patients ( suspected, possible, probable or definite per El-Escorial criteria).\n\nObservation', 'interventionNames': ['Other: Observation']}], 'interventions': [{'name': 'Observation', 'type': 'OTHER', 'armGroupLabels': ['ALS patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91120', 'city': 'Jerusalem', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Marc Gotkine, MBBS', 'role': 'CONTACT', 'email': 'marc@gotkine.com', 'phone': '+972507874692'}], 'facility': 'Hadassah Medical Organisation', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'Marc Gotkine, MBBS', 'role': 'CONTACT', 'email': 'marc@gotkine.com', 'phone': '+972507874692'}], 'overallOfficials': [{'name': 'Marc Gotkine, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hadassah Medical Organization'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Via specific collaboration agreements.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}