Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-04-11 @ 11:57 PM
Study NCT ID:
NCT02144467
Status:
UNKNOWN
Last Update Posted:
2022-08-03
First Post:
2014-05-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Establishment of Large-sample Database of "Multiple-MRI/Gene/Cognition"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Peripheral Venous Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-08-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-02', 'studyFirstSubmitDate': '2014-05-14', 'studyFirstSubmitQcDate': '2014-05-19', 'lastUpdatePostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The distribution of the amplitude of blood oxygenation level dependent(BOLD) signal in healthy subjects', 'timeFrame': 'up to 15 months', 'description': 'The amplitude of BOLD-functional magnetic resonance imaging(fMRI) signal is a common measure to estimate the brain activity during resting-state. We try to establish its distribution on healthy subjects, which could be a control to examine abnormal brain function in patients.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Multiple-MRI, Gene, Cognition'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '32147973', 'type': 'DERIVED', 'citation': 'Jing Y, Zhao N, Deng XP, Feng ZJ, Huang GF, Meng M, Zang YF, Wang J. Pregenual or subgenual anterior cingulate cortex as potential effective region for brain stimulation of depression. Brain Behav. 2020 Apr;10(4):e01591. doi: 10.1002/brb3.1591. Epub 2020 Mar 8.'}]}, 'descriptionModule': {'briefSummary': 'Aim to establish a large-sample database of "Multiple-MRI/Gene/Cognition" for healthy Chinese (sample number, 5000; age, 6-70 years). This is a fundamental but very necessary work for future researches such as development, aging, relation of gene and behavior, relation of gene and neuroimaging, relation of behavior and neuroimaging. Importantly, this work will provide a norm for researches on psychological or neurological patients. This large-sample will be shared with world-wide researchers.', 'detailedDescription': 'A part of data have been used in a publication which is preparing to submit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '6 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Residents of Hangzhou, China.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Chinese\n* Age: 6-70 years old\n* Right handed\n* No smoking or alcoholic addiction\n\nExclusion Criteria:\n\n* Psychological or neurological patients\n* Hypertension or cardiopathy patients\n* Pregnant woman\n* Take medicine or drink tea/coffee before scanning-'}, 'identificationModule': {'nctId': 'NCT02144467', 'briefTitle': 'The Establishment of Large-sample Database of "Multiple-MRI/Gene/Cognition"', 'organization': {'class': 'OTHER', 'fullName': 'Hangzhou Normal University'}, 'officialTitle': 'The Establishment of Large-sample Database of "Multiple-MRI/Gene/Cognition"', 'orgStudyIdInfo': {'id': 'HNU_CCBD_LargeSampleCollection'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Large-sample healthy participants', 'description': 'MRI scanning.', 'interventionNames': ['Device: MRI']}], 'interventions': [{'name': 'MRI', 'type': 'DEVICE', 'description': 'fMRI, sMRI, ASL and DTI', 'armGroupLabels': ['Large-sample healthy participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310010', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yu-Feng ZANG, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hangzhou Normal University,Center for Cognition and Brain Disorder', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Jue Wang, PHD', 'role': 'CONTACT', 'email': 'juefirst@163.com'}], 'overallOfficials': [{'name': 'Yu-Feng ZANG, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hangzhou Normal University, Center for Cognition and Brain Disorder'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data cannot be share with other researchers right now. It will be shared two years later.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hangzhou Normal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'deputy director', 'investigatorFullName': 'Yu-Feng ZANG', 'investigatorAffiliation': 'Hangzhou Normal University'}}}}