Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-02-28 @ 3:53 AM
Study NCT ID:
NCT04110457
Status:
COMPLETED
Last Update Posted:
2022-12-28
First Post:
2019-09-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes of Surgical Treatment of Patients With Spinal Metastasis in AUH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007796', 'term': 'Laminectomy'}], 'ancestors': [{'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D019299', 'term': 'Decompression, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-23', 'studyFirstSubmitDate': '2019-09-27', 'studyFirstSubmitQcDate': '2019-09-27', 'lastUpdatePostDateStruct': {'date': '2022-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate quality of life after surgery', 'timeFrame': 'baseline', 'description': 'to evaluate the general condition using 5Q-ED score'}], 'secondaryOutcomes': [{'measure': 'to analyze postoperative pain control , stability and ambulatory statues after surgical treatment of spinal metastases.', 'timeFrame': 'Baseline', 'description': 'evaluation of postoperative pain and neurology and comparing with preoperative data'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinal Metastases']}, 'referencesModule': {'references': [{'pmid': '12518372', 'type': 'BACKGROUND', 'citation': 'Hirabayashi H, Ebara S, Kinoshita T, Yuzawa Y, Nakamura I, Takahashi J, Kamimura M, Ohtsuka K, Takaoka K. Clinical outcome and survival after palliative surgery for spinal metastases: palliative surgery in spinal metastases. Cancer. 2003 Jan 15;97(2):476-84. doi: 10.1002/cncr.11039.'}, {'pmid': '22312491', 'type': 'RESULT', 'citation': 'Maccauro G, Spinelli MS, Mauro S, Perisano C, Graci C, Rosa MA. Physiopathology of spine metastasis. Int J Surg Oncol. 2011;2011:107969. doi: 10.1155/2011/107969. Epub 2011 Aug 10.'}]}, 'descriptionModule': {'briefSummary': 'To analyze the outcomes of surgical treatment of patients with spinal metastases in spine unit in AUH regarding the pain control, neurological status and ambulatory status as well as survival rate .', 'detailedDescription': 'this study monitor what is the results after operative treatment of patients which have secondary metastases in spinal column concerning quality of live for one year and pain and neurology'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with spinal metastases', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients \\> 18 years old\n* Patient with tissue proven dx of cancer\n\nExclusion Criteria:\n\n* Patient younger 18 years old\n* CNS or spinal 1ry tumor'}, 'identificationModule': {'nctId': 'NCT04110457', 'briefTitle': 'Outcomes of Surgical Treatment of Patients With Spinal Metastasis in AUH', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Outcomes of Surgical Treatment of Patients With Spinal Metastasis in Assiut University Hospitals', 'orgStudyIdInfo': {'id': 'surgical treatment in spine'}}, 'armsInterventionsModule': {'interventions': [{'name': 'spinal decompression', 'type': 'PROCEDURE', 'description': 'spinal surgery by decompression or fixation'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assuit university', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Essam El morshidy, PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'lecturer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Karim gamal asem', 'investigatorAffiliation': 'Assiut University'}}}}