Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 11:12 PM
Study NCT ID:
NCT06370793
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-05-23
First Post:
2024-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ningbo Schizophrenia Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26899}, 'targetDuration': '20 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-20', 'studyFirstSubmitDate': '2024-04-12', 'studyFirstSubmitQcDate': '2024-04-12', 'lastUpdatePostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Risk of circulatory system diseases', 'timeFrame': 'At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)', 'description': 'At least one of the following diagnoses in the electronic health records : Primary hypertension (I10), Cerebral infarction (I63), Transient cerebral ischaemic attacks and related syndromes (G45), Intracerebral haemorrhage (I61), Subarachnoid haemorrhage (I60), Hemorrhagic stroke (I60-I61), Stroke (I60-I64, I69), Pulmonary embolism (I26), Aortic aneurysm and dissection (I71), Cardiovascular disease (I20-I25), Atrial fibrillation (I48), Cardiomyopathy (I42), Peripheral vascular diseases (I73), Myocardial infarction (I21-I22), Heart failure (I50).\n\nCalculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.'}, {'measure': 'Risk of endocrine system diseases', 'timeFrame': 'At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)', 'description': 'At least one of the following diagnoses in the electronic health records : Diabetes mellitus (E10-E14), Thyroid disorder (E00-E05, E61-E69, E07), Gout (E79, M10).\n\nCalculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.'}, {'measure': 'Risk of pulmonary system and allergy diseases', 'timeFrame': 'At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)', 'description': 'At least one of the following diagnoses in the electronic health records : Chronic pulmonary disease (J40-J47), Allergy (J30.1-J30.4, L23, L50.0, T78.0, T78.2, T78.4).\n\nCalculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.'}, {'measure': 'Risk of gastrointestinal system diseases', 'timeFrame': 'At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)', 'description': 'At least one of the following diagnoses in the electronic health records : Ulcer/chronic gastritis (K22.1, K25-K28, K29.3-K29.5), Chronic liver disease (B16-B19, K70, K74, K76.6, I85), Inflammatory bowel disease (K50-K51), Diverticular disease of intestine (K57).\n\nCalculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.'}, {'measure': 'Risk of musculoskeletal system diseases', 'timeFrame': 'At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)', 'description': 'At least one of the following diagnoses in the electronic health records :Connective tissue disorders (M05-M06, M08-M09, M30-M36, D86), Osteoporosis (M80-M82).\n\nCalculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.'}, {'measure': 'Risk of urogenital system diseases', 'timeFrame': 'At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)', 'description': 'At least one of the following diagnoses in the electronic health records : Chronic kidney disease (N03, N11, N18-N19), Prostate disorders (N40).\n\nCalculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.'}, {'measure': 'Risk of hematological system diseases', 'timeFrame': 'At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)', 'description': 'At least one of the following diagnoses in the electronic health records : HIV/AIDS (B20-B24), Anemias (D50-D53, D55-D59, D60-D61, D63-D64).\n\nCalculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.'}, {'measure': 'Risk of cancers', 'timeFrame': 'At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)', 'description': 'Diagnosed with cancer (C00-C43, C45-C97) in electronic health records. Calculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.'}, {'measure': 'Risk of neurological system diseases', 'timeFrame': 'At least 1 year after being diagnosed with schizophrenia during the study period (2019-2023)', 'description': "At least one of the following diagnoses in the electronic health records :Vision problem (H40, H25, H54), Hearing problem (H90-H91, H93.1), Migraine (G43), Epilepsy (G40-G41), Parkinson's disease (G20-G22), Multiple sclerosis (G35), Neuropathies (G50-G64).\n\nCalculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia."}, {'measure': 'Risk of suicide', 'timeFrame': 'Recorded during the study period (2019-2023)', 'description': 'At least one of the following records in the Ningbo Mental Health Information System: attempted suicide, suicide, death by suicide.\n\nCalculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.'}, {'measure': 'Risk of violence', 'timeFrame': 'Recorded during the study period (2019-2023)', 'description': 'At least one of the following records in the Ningbo Mental Health Information System: causing trouble, causing an accident, committing an offence, injuring another person.\n\nCalculation of Hazard ratios(HRs) with 95% confidence intervals, comparing the risk of illness in persons with schizophrenia with those without schizophrenia.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Population-based healthcare database', 'Longitudinal study', 'Ambispective Cohort', 'Schizophrenia'], 'conditions': ['Schizophrenia']}, 'referencesModule': {'references': [{'pmid': '40379328', 'type': 'DERIVED', 'citation': 'Ye H, Zhao Y, Li L, Qian Y, Zhu H, Bian G, Liu L. Ningbo Schizophrenia Cohort (NSC)-a longitudinal ambispective cohort based on electronic health records: cohort profile. BMJ Open. 2025 May 15;15(5):e091188. doi: 10.1136/bmjopen-2024-091188.'}]}, 'descriptionModule': {'briefSummary': "In recent years, the prevalence of schizophrenia in China has continued to grow, and the burden of disease in society has continued to rise. In order to improve the prognosis of patients with schizophrenia and reduce the risk of disease relapse or readmission, researchers established a cohort based on the Ningbo Mental Health Information System in Ningbo, a sub-provincial city in the southern wing of the Yangtze River Delta of China, with a resident population of more than 9 million, and linked it to the residents' health records, and through the data linkage obtained data on patients in the full cycle of pre-onset, diagnosis, follow-up, disease changes and death, realising full-cycle management of patients with schizophrenia.\n\nCurrently, NSC has accumulated data on more than 30,000 patients with schizophrenia and obtained multi-dimensional longitudinal information through long-term follow-up and data linkage. All diseases follow the World Health Organization International Classification of Diseases 10th Edition (ICD-10) for clinical coding, and available data include baseline demographics, past history, family history, social functioning deficit screening scale scores, risk assessment, and so on and longitudinal health information from electronic health records (EHR), providing a solid data base for future real-world studies."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients were eligible if they were aged 18-65 years at diagnosis and had a diagnosis of schizophrenia confirmed by at least two independent visit records in the EHR. Additionally, they were required to provide signed informed consent, either personally or through their legal representatives, and possess complete electronic health records, including date of birth, gender, and a valid medical identifier. Subjects meeting any of the following criteria were not eligible to participate: (1) history of severe neurological diseases, including epilepsy, encephalitis, or brain tumours or (2) history of severe head trauma resulting in unconsciousness, to exclude trauma-induced psychotic symptoms.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of schizophrenia (F20)\n* Aged 18-65 years at the time of diagnosis\n\nExclusion Criteria:\n\n* None.'}, 'identificationModule': {'nctId': 'NCT06370793', 'acronym': 'NSC', 'briefTitle': 'Ningbo Schizophrenia Cohort', 'organization': {'class': 'OTHER', 'fullName': 'Ningbo University'}, 'officialTitle': 'Ningbo Schizophrenia Cohort, a Longitudinal Population-based Ambispective Cohort Study', 'orgStudyIdInfo': {'id': 'NBU-2024-011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Schizophrenia', 'interventionNames': ['Other: Patient with schizophrenia without intervention']}], 'interventions': [{'name': 'Patient with schizophrenia without intervention', 'type': 'OTHER', 'description': 'Patients with schizophrenia identified based on exposures of interest to the study', 'armGroupLabels': ['Patients with Schizophrenia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '315000', 'city': 'Ningbo', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Ningbo University', 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ningbo University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Affiliated Kangning Hospital of Ningbo University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Liya Liu', 'investigatorAffiliation': 'Ningbo University'}}}}