Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2026-02-09 @ 5:47 AM
Study NCT ID:
NCT03224650
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2017-07-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of Novel Predictive Score for Patients With Spinal Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 219}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-01', 'studyFirstSubmitDate': '2017-07-14', 'studyFirstSubmitQcDate': '2017-07-19', 'lastUpdatePostDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Survival', 'timeFrame': 'Up to 3 years', 'description': 'Mortality is documented using date of death in medical record'}, {'measure': 'EuroQuol 5-Dimension (EQ5D) profile', 'timeFrame': 'Up to 3 years', 'description': 'Assessment of state of health and physical/mental function'}, {'measure': 'Short-Form (SF)-12', 'timeFrame': 'Up to 3 years', 'description': 'Assessment of state of health and physical/mental function'}, {'measure': 'Visual Analog Scale (VAS) for pain', 'timeFrame': 'Up to 3 years', 'description': 'Assessment of current level of pain'}, {'measure': 'Patient-Reported Outcomes Measurement Information System (PROMIS)', 'timeFrame': 'Up to 3 years', 'description': 'Assessment of global health'}], 'secondaryOutcomes': [{'measure': 'Post-treatment morbidity and readmissions', 'timeFrame': 'Up to 3 years', 'description': 'Post treatment complications and readmissions documented in medical record'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinal Metastases']}, 'referencesModule': {'references': [{'pmid': '35181541', 'type': 'DERIVED', 'citation': 'Xiong GX, Collins JE, Ferrone ML, Schoenfeld AJ. Prospective comparison of one-year survival in patients treated operatively and nonoperatively for spinal metastatic disease: results of the prospective observational study of spinal metastasis treatment (POST). Spine J. 2023 Jan;23(1):14-17. doi: 10.1016/j.spinee.2022.02.004. Epub 2022 Feb 16. No abstract available.'}]}, 'descriptionModule': {'briefSummary': "The investigators are prospectively validating a prognostic clinical tool that uses a patient's modified Bauer grade, ambulatory status, and pre-operative serum albumin to predict survival, post-treatment morbidity, and functional outcomes in patients with metastatic disease involving the spine.", 'detailedDescription': "Recently, the investigators proposed a clinical prediction score that used a patient's modified Bauer grade, ambulatory status, and pre-operative serum albumin as a means to predict long-term survival following spine surgery for metastatic disease. This prognostic utility was developed using one-year mortality as the sole outcome measure. While the scoring system demonstrated many of the necessary attributes of a useful prediction tool, including simplicity, ease of use and clinical utility, it has yet to be validated prospectively and its capacity to predict other peri-operative outcomes, including physical and mental function following intervention, pain relief and the risk of complications, remain incompletely explored. To further evaluate the utility of this prognostic score, the investigators propose a series of three integrated experiments that will prospectively determine its capacity to accurately inform clinical decision making and recommendations for surgery for patients with metastatic spinal disease."}, '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\n1. ≥ 18 years of age\n2. Confirmed diagnosis of cancer with metastatic spread to the mobile spine or sacrum\n3. Able to consent for themselves at the time of the intake evaluation\n4. Speaks English\n\n Exclusion Criteria:\n5. Primary bone tumors or leukemia\n6. Metastases to other visceral or skeletal locations, without involvement of the spine or sacrum\n7. History of prior spine surgery for metastatic disease'}, 'identificationModule': {'nctId': 'NCT03224650', 'briefTitle': 'Validation of Novel Predictive Score for Patients With Spinal Metastases', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Validation of Novel Predictive Score for Patients With Spinal Metastases', 'orgStudyIdInfo': {'id': '2017P000203'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surgical', 'description': 'Patients treated surgically for spinal metastases'}, {'label': 'Non-operative', 'description': 'Patients treated non-operatively for spinal metastases'}, {'label': 'Expectant', 'description': 'Patients receiving no treatment for spinal metastases'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Andrew Schoenfeld, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Andrew Schoenfeld', 'investigatorAffiliation': "Brigham and Women's Hospital"}}}}