Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:26 PM
Study NCT ID:
NCT07143656
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-28
First Post:
2025-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Amyotrophic Lateral Sclerosis: A Multicenter Retrospective Observational Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014965', 'term': 'X-Rays'}], 'ancestors': [{'id': 'D060733', 'term': 'Electromagnetic Radiation'}, {'id': 'D055590', 'term': 'Electromagnetic Phenomena'}, {'id': 'D060328', 'term': 'Magnetic Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D011839', 'term': 'Radiation, Ionizing'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-05-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2025-08-20', 'studyFirstSubmitQcDate': '2025-08-20', 'lastUpdatePostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-08-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of decline in ALS Functional Rating Scale-Revised (ALSFRS-R) scores', 'timeFrame': '2 yearss after the first administration', 'description': 'Unit: points per month'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Amyotrophic Lateral Sclerosis', 'MSC', 'biomedicine'], 'conditions': ['Amyotrophic Lateral Sclerosis (ALS)', 'Amyotrophic Lateral Sclerosis &Amp; Other Neuromuscular Disorders']}, 'descriptionModule': {'briefSummary': 'This retrospective observational study will analyze de-identified clinical data from patients with amyotrophic lateral sclerosis (ALS) collected at multiple centers over 7 years. The primary objective is to describe disease progression using the ALS Functional Rating Scale-Revised (ALSFRS-R). Secondary objectives include evaluating survival, ventilatory decline, and correlations between available biomarkers (e.g., neurofilament light chain, cytokines) and disease trajectory. No new interventions or patient contact will occur.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'People aged ≥18 with ALS', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of amyotrophic lateral sclerosis (ALS) or motor neuron disease confirmed.\n2. Age ≥18 years.\n3. Availability of at least one ALS Functional Rating Scale-Revised (ALSFRS-R) score.\n4. Availability of longitudinal follow-up data.\n\nExclusion Criteria:\n\n1. Patients with alternative diagnoses that mimic ALS (e.g., multifocal motor neuropathy, cervical myelopathy, myasthenia gravis).\n2. Absence of medical records'}, 'identificationModule': {'nctId': 'NCT07143656', 'briefTitle': 'Amyotrophic Lateral Sclerosis: A Multicenter Retrospective Observational Registry', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biocells Medical'}, 'officialTitle': 'Natural History and Biomarker Correlation Study in Amyotrophic Lateral Sclerosis: A Multicenter Retrospective Observational Registry', 'orgStudyIdInfo': {'id': 'Bio120003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Imaging and Clinical Reports', 'type': 'BIOLOGICAL', 'description': 'Inclusion of existing imaging data (MRI, EMG reports) and standard clinical documentation, where available.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Warsaw', 'country': 'Poland', 'facility': 'Biocells Medical', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biocells Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}