Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-07 @ 10:44 PM
Study NCT ID:
NCT02934594
Status:
UNKNOWN
Last Update Posted:
2016-10-17
First Post:
2016-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metastatic Spinal Cord Compression (MSCC): Treatment Timing and Survival Rate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D013117', 'term': 'Spinal Cord Compression'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-13', 'studyFirstSubmitDate': '2016-10-11', 'studyFirstSubmitQcDate': '2016-10-13', 'lastUpdatePostDateStruct': {'date': '2016-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'survival rate', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Neoplasm Metastasis', 'Spinal Cord Compression']}, 'referencesModule': {'references': [{'pmid': '16205345', 'type': 'BACKGROUND', 'citation': 'Tokuhashi Y, Matsuzaki H, Oda H, Oshima M, Ryu J. A revised scoring system for preoperative evaluation of metastatic spine tumor prognosis. Spine (Phila Pa 1976). 2005 Oct 1;30(19):2186-91. doi: 10.1097/01.brs.0000180401.06919.a5.'}, {'pmid': '11224867', 'type': 'BACKGROUND', 'citation': 'Tomita K, Kawahara N, Kobayashi T, Yoshida A, Murakami H, Akamaru T. Surgical strategy for spinal metastases. Spine (Phila Pa 1976). 2001 Feb 1;26(3):298-306. doi: 10.1097/00007632-200102010-00016.'}]}, 'descriptionModule': {'briefSummary': 'Patients with metastatic spinal cord compression (MSCC) are treated with different options according to the life expectancy. Survival and surgical outcome can be influenced by surgical timing in MSCC patients treated with palliative decompression.', 'detailedDescription': 'MSCC patients who underwent palliative decompression after January 2012 in National Taiwan University Hospital (NTUH) were divided into the preoperative motor function intact group (Group A) and motor deficit group (Group B). The motor deficit group was subdivided into operation within 48 hours (Group B1), and after 48 hours (Group B2). All patients underwent palliative decompression and posterior stabilization. Investigators did wide laminectomy for tumor invading the vertebral body, and debulking surgery for tumor destructing the posterior column of the spine. Investigators retrospectively reviewed all patient records, including patient demographics, prognostic factors for survival (Kaplan-Meier survival analysis), neurological outcome (Frankel grade), primary tumor, complications, and relevance of Tomita and Tokuhashi scores.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with metastatic spinal cord compression (MSCC) who underwent palliative decompression.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with metastatic spinal cord compression (MSCC) who underwent palliative decompression in National Taiwan University Hospital after January 1st, 2012.\n\nExclusion Criteria:\n\n* Patients with metastatic spinal cord compression (MSCC) who underwent palliative decompression before December 31st, 2011, or those who were not treated in National Taiwan University Hospital.'}, 'identificationModule': {'nctId': 'NCT02934594', 'briefTitle': 'Metastatic Spinal Cord Compression (MSCC): Treatment Timing and Survival Rate', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Metastatic Spinal Cord Compression (MSCC): Treatment Timing and Survival Rate', 'orgStudyIdInfo': {'id': '201608007RIND'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A', 'description': 'Motor function intact group: received palliative decompression', 'interventionNames': ['Other: Palliative Decompression']}, {'label': 'Group B1', 'description': 'motor deficit group: received palliative decompression within 48 hours after symptoms occured', 'interventionNames': ['Other: Palliative Decompression']}, {'label': 'Group B2', 'description': 'motor deficit group: received palliative decompression 48 hours after symptoms occured', 'interventionNames': ['Other: Palliative Decompression']}], 'interventions': [{'name': 'Palliative Decompression', 'type': 'OTHER', 'description': 'palliative decompression to MSCC patients: before motor deficit (Group A), within 48 hours after motor deficit (Group B1), 48 hours after motor deficit (Group B2)', 'armGroupLabels': ['Group A', 'Group B1', 'Group B2']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Shu-Hua Yang, M.D., Ph.D.', 'role': 'CONTACT', 'email': '005964@ntuh.gov.tw', 'phone': '886-2-23123456', 'phoneExt': '63981'}], 'overallOfficials': [{'name': 'Shu-Hua Yang, M.D., Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'National Taiwan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}