Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT07175935
Status:
RECRUITING
Last Update Posted:
2025-09-16
First Post:
2025-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Amyotrophic Lateral Sclerosis Registry in Thailand
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-14', 'studyFirstSubmitDate': '2025-08-27', 'studyFirstSubmitQcDate': '2025-09-14', 'lastUpdatePostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': '10 years', 'description': 'Time Frame: From enrollment until death from any cause (assessed continuously, with updates at each follow-up).\n\nOutcome: Overall survival in ALS patients across Thailand, with survival curves stratified by demographic, clinical, and genetic factors.'}], 'secondaryOutcomes': [{'measure': 'ALS Functional Decline', 'timeFrame': '10 years', 'description': 'Measure: Change in ALS Functional Rating Scale-Revised (ALSFRS-R) score.\n\nTime Frame: Every 6-12 months.\n\nOutcome: Rate of functional decline, expressed as points lost per month/year.'}, {'measure': 'Disease Staging Progression', 'timeFrame': '10 years', 'description': "Measure: King's and MiToS staging systems, 9-point staging.\n\nTime Frame: Every 6-12 months.\n\nOutcome: Proportion of patients progressing to higher stages; median time to stage transitions."}, {'measure': 'Respiratory Outcomes', 'timeFrame': '10 years', 'description': 'Measure: Forced vital capacity (FVC % predicted).\n\nTime Frame: Every 6-12 months.\n\nOutcome: Decline in FVC'}, {'measure': 'Changes in health-related quality of life over time.', 'timeFrame': '10 years', 'description': 'Measure: EQ-5D-5L.\n\nTime Frame: Annually.\n\nOutcome: Changes in health-related quality of life over time.'}, {'measure': 'Cognitive and Behavioral Profile', 'timeFrame': '10 years', 'description': 'Measure: Edinburgh Cognitive and Behavioral ALS Screen (ECAS)\n\nTime Frame: Annually.\n\nOutcome: Frequency and pattern of cognitive/behavioral impairment in ALS patients.'}, {'measure': 'Genetic and Environmental Risk Associations', 'timeFrame': '10 years', 'description': 'Measure: Frequency of ALS-associated genetic variants (e.g., SOD1, C9orf72, TARDBP, FUS) and correlation with clinical phenotype and progression.\n\nTime Frame: As available.\n\nOutcome: Genotype-phenotype correlation; association with disease onset, progression, and survival.'}, {'measure': 'Healthcare Utilization and Treatment Patterns', 'timeFrame': '10 years', 'description': 'Measure: Use of riluzole, edaravone, non-invasive ventilation, gastrostomy, and multidisciplinary ALS clinic care.\n\nTime Frame: Throughout follow-up.\n\nOutcome: Patterns of treatment access and their association with survival and quality of life.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Amyotrophic Lateral Sclerosis', 'Epidemiological', 'Natural History'], 'conditions': ['ALS (Amyotrophic Lateral Sclerosis)']}, 'descriptionModule': {'briefSummary': 'This is a prospective, observational, multicenter registry designed to collect comprehensive clinical, genetic, and outcome data from patients diagnosed with amyotrophic lateral sclerosis (ALS) across Thailand. The registry will establish a national dataset to describe epidemiology, clinical presentation, progression, and treatment outcomes, and will serve as a platform for future clinical and translational research.', 'detailedDescription': 'Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disorder that affects upper and lower motor neurons, leading to progressive muscle weakness, disability, and respiratory failure. Despite increasing research worldwide, Thailand lacks large-scale systematic data on ALS epidemiology, clinical characteristics, genetic profiles, and outcomes.\n\nThis registry will prospectively enroll ALS patients from major academic hospitals and specialized neuromuscular centers nationwide. Patients will be followed longitudinally using standardized assessments, including ALSFRS-R, staging systems (King, MiTos, 9-point), motor and respiratory function, quality-of-life measures, and cognitive/behavioral evaluations.\n\nData will be collected through a REDCap electronic database, ensuring confidentiality and compliance with Thai PDPA and international data protection standards. No experimental interventions will be performed; patients will receive standard of care treatments as determined by their treating physicians.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'ALS patients attending university hospitals, tertiary neuromuscular clinics, and referral hospitals in Thailand.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of ALS according to El Escorial or Gold Coast criteria\n* Age ≥ 18 years\n* Ability and willingness to provide informed consent\n\nExclusion Criteria:\n\n* Patients unwilling to provide informed consent\n* Patients with alternative diagnoses mimicking ALS'}, 'identificationModule': {'nctId': 'NCT07175935', 'acronym': 'Thai ALS Regis', 'briefTitle': 'Amyotrophic Lateral Sclerosis Registry in Thailand', 'organization': {'class': 'OTHER', 'fullName': 'Chulalongkorn University'}, 'officialTitle': 'A Prospective, Multicenter Registry Study of Amyotrophic Lateral Sclerosis in Thailand', 'orgStudyIdInfo': {'id': 'COA No. 0262/2025'}, 'secondaryIdInfos': [{'id': 'NST', 'type': 'OTHER_GRANT', 'domain': 'The Neurological Society of Thailand'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Pathum Wan', 'state': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Jakkrit Amornvit, MD', 'role': 'CONTACT', 'email': 'jakkrit.a@chula.ac.th', 'phone': '+66622169338'}, {'name': 'Phuettha Sangrut, MSc', 'role': 'CONTACT', 'email': 'phuettha.s@chulahospital.org', 'phone': '022564000', 'phoneExt': '80722'}], 'facility': 'King Chulalongkorn Memorial hospital, The Thai Red Cross Society', 'geoPoint': {'lat': 13.73649, 'lon': 100.5239}}], 'centralContacts': [{'name': 'Jakkrit Amornvit, MD', 'role': 'CONTACT', 'email': 'jakkrit.a@chula.ac.th', 'phone': '+66622169338'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'IPD will be available beginning 6-12 months after publication of the primary results and for up to 5 years thereafter.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) underlying the results of this study (including clinical, demographic, and outcome measures) will be made available to qualified researchers upon reasonable request, following publication of the primary results. Access will be provided to investigators whose proposed use of the data has been approved by an independent review committee to ensure scientific merit and compliance with ethical standards. Data will be shared through secure data transfer under a data sharing agreement that protects participant confidentiality. Supporting documents, including the study protocol, statistical analysis plan, and informed consent form, will also be made available where applicable.', 'accessCriteria': 'Requests for access should be directed to the Principal Investigator via institutional contact email. Applicants will be required to submit a research proposal outlining objectives, methods, and intended use of the data. Approval will be contingent on adherence to ethical and scientific standards, and execution of a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulalongkorn University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Priciple Investigator', 'investigatorFullName': 'Jakkrit Amornvit, MD.', 'investigatorAffiliation': 'Chulalongkorn University'}}}}