Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-25 @ 7:17 PM
Study NCT ID:
NCT05867732
Status:
COMPLETED
Last Update Posted:
2023-05-22
First Post:
2023-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multicenter Observational Cohort of Degenerative Spine Diseases in China（DSDC）
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10000}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-19', 'studyFirstSubmitDate': '2023-05-11', 'studyFirstSubmitQcDate': '2023-05-19', 'lastUpdatePostDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Collect demographics (Hospital Information System)', 'timeFrame': '2022.03', 'description': 'Collect demographics from the HIS system for patients with degenerative spine disease'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Degenerative Spine Diseases']}, 'referencesModule': {'references': [{'pmid': '40540437', 'type': 'DERIVED', 'citation': 'Shen N, Zhang Y, Ding Z, Li R, Quan X, Liu X, Zhang Y, Xiang T, Zhang Y, Yin C, Li W. Predicting intraoperative blood loss risk in severe lumbar disc herniation patients undergoing PLIF: a multicenter cohort study using ensemble learning. Int J Surg. 2025 Sep 1;111(9):5904-5913. doi: 10.1097/JS9.0000000000002730. Epub 2025 Jun 19.'}, {'pmid': '38308336', 'type': 'DERIVED', 'citation': 'Li W, Zhang Y, Zhou X, Quan X, Chen B, Hou X, Xu Q, He W, Chen L, Liu X, Zhang Y, Xiang T, Li R, Liu Q, Wu SN, Wang K, Liu W, Zheng J, Luan H, Yu X, Chen A, Xu C, Luo T, Hu Z. Ensemble learning-assisted prediction of prolonged hospital length of stay after spine correction surgery: a multi-center cohort study. J Orthop Surg Res. 2024 Feb 2;19(1):112. doi: 10.1186/s13018-024-04576-4.'}]}, 'descriptionModule': {'briefSummary': 'Study type: The objectives of this observational study were to understand, analyze, and compare the treatment and prognosis of patients with degenerative spine diseases and to construct a risk warning model and an assisted decision-making system\n\nThe main questions it aims to answer are:\n\n* \\[question 1\\] to construct a database of patients with degenerative spinal diseases and to study their associated prognosis, complications, and other risks\n* \\[Question 2\\] Use big data to build a risk early warning model and assisted decision making system The study will not intervene with patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with degenerative spine disease (lumbar disc herniation, lumbar spinal stenosis, lumbar spondylolisthesis, scoliosis deformity, etc.) seen and treated in participating units between January 2015 and January 2022, excluding patients with neoplastic disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* patients with degenerative spine disease admitted to the units participating in the study from January 2015 to mid-January 2022;\n* complete patient data with no more than 5% missing;\n\nExclusion Criteria:\n\n* Patients with oncology;'}, 'identificationModule': {'nctId': 'NCT05867732', 'acronym': 'DSDC', 'briefTitle': 'A Multicenter Observational Cohort of Degenerative Spine Diseases in China（DSDC）', 'organization': {'class': 'OTHER', 'fullName': 'Xiamen University'}, 'officialTitle': 'A Multicenter Observational Cohort of Degenerative Spine Diseases in China', 'orgStudyIdInfo': {'id': 'XiamenUDSDC'}}, 'contactsLocationsModule': {'locations': [{'zip': '361102', 'city': 'Xianmencun', 'country': 'China', 'facility': 'Wenle Li', 'geoPoint': {'lat': 27.98124, 'lon': 120.57686}}], 'overallOfficials': [{'name': 'Wenle Wenle, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Xiamen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiamen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Wenle Li', 'investigatorAffiliation': 'Xiamen University'}}}}