Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT06910618
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-04
First Post:
2025-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multicenter Prospective Observational Study on Vertebral Fracture Risk Stratification in Patients With Vertebral Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016103', 'term': 'Spinal Fractures'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D050723', 'term': 'Fractures, Bone'}], 'ancestors': [{'id': 'D013124', 'term': 'Spinal Injuries'}, {'id': 'D019567', 'term': 'Back Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-28', 'studyFirstSubmitDate': '2025-03-28', 'studyFirstSubmitQcDate': '2025-03-28', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'new vertebral fracture', 'timeFrame': 'in 6 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['vertebral metastasis', 'cancer', 'fracture', 'risk stratification'], 'conditions': ['Vertebral Metastases', 'Vertebral Fracture']}, 'descriptionModule': {'briefSummary': "Vertebral fracture is a common clinically significant skeletal related event in cancer patients. Stratification of patients diagnosed with one or more vertebral metastases according to the risk of pathological fracture is an unresolved problem despite the fact that fractures strongly influence the quality of life (QoL) and also the overall survival. The multidimensional nature and the strong patient specificity of the risk for fracture have not been considered in previously published risk estimation models and these methods were developed and validated only on retrospective data focusing on prevalence of life-time fracture which is not really relevant at the time of the diagnosis of a vertebral metastasis. To overcome these shortcomings, the METASTRA models (METASTRA-AI and METASTRA-VPH) and the decision support system (METASTRA-DSS) are developed considering the highest possible level of patient specificity to stratify the individuals according to their risk for fracture in a clinically considerable period (within next 6 months). The prospective data collection and analysis will provide reliability and validity results on the performance of METASTRA tools as well as structured information on user's experience helping the future integration of the developed patient-specific stratification tool into the everyday clinical practice.\n\nThe study is a prospective clinical data collection from minimum 200 patients to determine the validity (i.e. Precision) in fracture risk stratification of the METASTRA-AI and METASTRA-VPH computational models and to determine the reliability of METASTRA-AI and METASTRA-VPH as well as human decision making process in patient stratification."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': False, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient diagnosed with a metastatic tumor in the thoracic and/or lumbar spine (one or more vertebral metastases in the spinal region between T1 and L5 vertebrae)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient 18 years or older\n* Patient diagnosed with a metastatic tumor in the thoracic and/or lumbar spine (one or more vertebral metastases in the spinal region between T1 and L5 vertebrae)\n* Min. 1 vertebra is potentially unstable based on SINS score (SINS is 7-12) and it has not been surgically stabilized previously (level of interest - LOI)\n* Adjacent vertebrae are not surgically stabilized at the time of the enrollment\n* Patient willing to complete 6-month follow-up\n* Patient is willing and able to provide written informed consent after the nature of the study has been explained:\n\n * Ability to understand the content of the patient information/ ICF\n * Willingness and ability to participate in the study according to the protocol\n * Signed and dated EC approved written informed consent\n\nExclusion Criteria:\n\n* Poor general status at baseline (Karnofsky scale less than 40%)\n* Expected life expectancy is less than 3 months at baseline\n* Spinal infection\n* Ongoing litigation\n* Participation in investigational clinical study at the same time or within 3 months\n* Vertebral lesion/metastasis from a hematologic condition (e.g. multiple myeloma)'}, 'identificationModule': {'nctId': 'NCT06910618', 'acronym': 'Valid-METASTRA', 'briefTitle': 'A Multicenter Prospective Observational Study on Vertebral Fracture Risk Stratification in Patients With Vertebral Metastases', 'organization': {'class': 'OTHER', 'fullName': 'Buda Health Center'}, 'officialTitle': 'A Multicenter Prospective Observational Study on Vertebral Fracture Risk Stratification in Patients With Vertebral Metastases', 'orgStudyIdInfo': {'id': 'EUMET-101080135'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with vertebral metastasis in ThL region', 'description': 'Patient diagnosed with a metastatic tumor in the thoracic and/or lumbar spine (one or more vertebral metastases in the spinal region between T1 and L5 vertebrae)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'contacts': [{'name': 'Peter Vajkoczy, Prof. Dr. med', 'role': 'CONTACT', 'email': 'peter.vajkoczy@charite.de'}], 'facility': 'Department of Neurosurgery Charité Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '1126', 'city': 'Budapest', 'country': 'Hungary', 'contacts': [{'name': 'Aron Lazary, MD PhD', 'role': 'CONTACT', 'email': 'aron.lazary@bhc.hu', 'phone': '+36304847552'}], 'facility': 'Buda Health Center', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'city': 'Bologna', 'country': 'Italy', 'contacts': [{'name': 'Giovanni Barbanti Brodano, MD', 'role': 'CONTACT', 'email': 'giovanni.barbantibrodano@ior.it'}], 'facility': 'IRCCS Istituto Ortopedico Rizzoli', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Utrecht', 'country': 'Netherlands', 'contacts': [{'name': 'Jorrit-Jan Verlaan, MD PhD', 'role': 'CONTACT', 'email': 'j.j.verlaan@umcutrecht.nl'}], 'facility': 'University Medical Center Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'centralContacts': [{'name': 'Aron Lazary, MD PhD', 'role': 'CONTACT', 'email': 'aron.lazary@bhc.hu', 'phone': '+36304847552'}, {'name': 'Julia Szita, PhD', 'role': 'CONTACT', 'email': 'julia.szita@bhc.hu', 'phone': '+36205971605'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Buda Health Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}