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

NCT ID: NCT06910618

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2027-08-01

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.

Conditions

Vertebral Metastases; Vertebral Fracture

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with vertebral metastasis in ThL region

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)

No interventions assigned to this group

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Buda Health Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Neurosurgery Charité Berlin

Berlin, , Germany

Buda Health Center

Budapest, , Hungary

IRCCS Istituto Ortopedico Rizzoli

Bologna, , Italy

University Medical Center Utrecht

Utrecht, , Netherlands

Countries

Germany; Hungary; Italy; Netherlands

Central Contacts

Aron Lazary, MD PhD

Role: CONTACT

aron.lazary@bhc.hu

+36304847552

Julia Szita, PhD

Role: CONTACT

julia.szita@bhc.hu

+36205971605

Facility Contacts

Peter Vajkoczy, Prof. Dr. med

Role: primary

peter.vajkoczy@charite.de

Aron Lazary, MD PhD

Role: primary

aron.lazary@bhc.hu

+36304847552

Giovanni Barbanti Brodano, MD

Role: primary

giovanni.barbantibrodano@ior.it

Jorrit-Jan Verlaan, MD PhD

Role: primary

j.j.verlaan@umcutrecht.nl

Other Identifiers

EUMET-101080135

Identifier Type: -

Identifier Source: org_study_id