Status:
NOT_YET_RECRUITING
A Multicenter Prospective Observational Study on Vertebral Fracture Risk Stratification in Patients With Vertebral Metastases
Lead Sponsor:
Buda Health Center
Conditions:
Vertebral Metastases
Vertebral Fracture
Eligibility:
All Genders
18+ years
Brief Summary
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 pat...
Eligibility Criteria
Inclusion
- Patient 18 years or older
- 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)
- 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)
- Adjacent vertebrae are not surgically stabilized at the time of the enrollment
- Patient willing to complete 6-month follow-up
- Patient is willing and able to provide written informed consent after the nature of the study has been explained:
- Ability to understand the content of the patient information/ ICF
- Willingness and ability to participate in the study according to the protocol
- Signed and dated EC approved written informed consent
Exclusion
- Poor general status at baseline (Karnofsky scale less than 40%)
- Expected life expectancy is less than 3 months at baseline
- Spinal infection
- Ongoing litigation
- Participation in investigational clinical study at the same time or within 3 months
- Vertebral lesion/metastasis from a hematologic condition (e.g. multiple myeloma)
Key Trial Info
Start Date :
April 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06910618
Start Date
April 1 2025
End Date
August 1 2027
Last Update
April 4 2025
Active Locations (4)
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1
Department of Neurosurgery Charité Berlin
Berlin, Germany
2
Buda Health Center
Budapest, Hungary, 1126
3
IRCCS Istituto Ortopedico Rizzoli
Bologna, Italy
4
University Medical Center Utrecht
Utrecht, Netherlands