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ClinicalTrials.gov ID

NCT06910618

Lead Sponsor

Buda Health CenterOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

300Estimated

Last Update Posted

Apr 4, 2025Actual

Start Date

Apr 1, 2025Estimated

Primary Completion Date

Apr 1, 2027Estimated

Completion Date

Aug 1, 2027Estimated

Official Title

A Multicenter Prospective Observational Study on Vertebral Fracture Risk Stratification in Patients With Vertebral Metastases

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 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.

The 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.

• Vertebral Metastases
• Vertebral Fracture

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Buda Health CenterOTHER

aron.lazary@bhc.hu+36304847552

giovanni.barbantibrodano@ior.it

j.j.verlaan@umcutrecht.nl