Ignite Creation Date:
2025-12-25 @ 4:11 AM
Ignite Modification Date:
2025-12-26 @ 3:09 AM
Study NCT ID:
NCT06367920
Status:
RECRUITING
Last Update Posted:
2025-09-17
First Post:
2024-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multicenter Study on Rehabilitation Medical Data for Pediatric Big Brain Development
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}], 'ancestors': [{'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-15', 'studyFirstSubmitDate': '2024-04-11', 'studyFirstSubmitQcDate': '2024-04-11', 'lastUpdatePostDateStruct': {'date': '2025-09-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain magnetic resonance imaging', 'timeFrame': 'A time point at which imaging was performed between January 1, 2010 and December 31, 2024', 'description': 'MRI scan is a process of measuring anatomical changes of brain and tract fiber'}], 'secondaryOutcomes': [{'measure': 'Medical records', 'timeFrame': 'A time point at which recording medical examinations was performed between January 1, 2010 and December 31, 2024', 'description': 'Medical records including basic characteristics and behavioral assessments'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pediatric ALL', 'Healthy']}, 'descriptionModule': {'briefSummary': 'Retrospective study for development of imaging-genetics (brain imaging/genome big data) models and algorithms that are clinically explainable and have high predictive performance in brain research on pediatric developmental disorders', 'detailedDescription': 'Retrospective study for development of imaging-genetics (brain imaging/genome big data) models and algorithms that are clinically explainable and have high predictive performance in brain research on pediatric developmental disorders'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy subjects and patients 20 years old or younger who underwent imaging examinations performed at the Department of Rehabilitation Medicine at our hospital from January 2010 to December 2023 (patients who underwent brain MRI tests to determine the cause of developmental delay)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects and patients 20 years old or younger who underwent imaging examinations performed at the Department of Rehabilitation Medicine at our hospital from January 2010 to December 2023 (patients who underwent brain MRI tests to determine the cause of developmental delay)\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT06367920', 'briefTitle': 'Multicenter Study on Rehabilitation Medical Data for Pediatric Big Brain Development', 'organization': {'class': 'OTHER', 'fullName': 'Bundang CHA Hospital'}, 'officialTitle': 'Multicenter Study on Rehabilitation Medical Data for Pediatric Big Brain', 'orgStudyIdInfo': {'id': '2022-02-005'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Magnetic Resonance Imaging, Behavioral assessments', 'type': 'DIAGNOSTIC_TEST', 'description': 'Magnetic Resonance Imaging, Behavioral assessments'}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-712', 'city': 'Seongnam-si', 'state': 'Gyeonggi-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Minyoung Kim, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'kmin@cha.ac.kr', 'phone': '82-31-780-1872'}], 'facility': 'CHA Bundang Medical Center, CHA University', 'geoPoint': {'lat': 37.43861, 'lon': 127.13778}}], 'centralContacts': [{'name': 'So young Choi, BS', 'role': 'CONTACT', 'email': 'csy505@chamc.co.kr', 'phone': '+82 031 780 6003', 'phoneExt': '6003'}], 'overallOfficials': [{'name': 'Minyoung Kim, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bundang CHA Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bundang CHA Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'MinYoung Kim, MD, PhD', 'investigatorAffiliation': 'Bundang CHA Hospital'}}}}