Multicentric European Study In Patients With Vertebral Metastases

Completed

• Conditions: Spinal Metastases
• Interventions: Other: Case series review of clinical and radiographic data

• Registration Number: NCT06220071
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief Summary

Train-METASTRA is a retrospective study that will be performed in order to collect a large and harmonised amount of clinical and imaging data concerning vertebral metastases, focusing in particular on the risk of fractures. This type of dataset will be created from the medical records of 2000 patients admitted in the last ten years in the four European clinical centers participating in METASTRA project: "COMPUTER-AIDED EFFECTIVE FRACTURE RISK STRATIFICATION OF PATIENTS WITH VERTEBRAL METASTASES FOR PERSONALISED TREATMENT THROUGH ROBUST COMPUTATIONAL MODELS VALIDATED IN CLINICAL SETTINGS", funded by the European Union under the call "HORIZON-HLTH-2022-TOOL-12-two-stage/Computational models for new patient stratification strategies". The project is coordinated by the University of Bologna (UNIBO) (PI prof. Luca Cristofolini) and involves 15 European partners, including Sarl Voisin Consulting Life Sciences VCLS, University of Szeged (Hungary), University of Sheffield (UK) and FrontEndART (Hungary).

This type of dataset is not currently available in the literature and it will be pivotal to the development of the METASTRA computational models for the stratification of the risk of fracture of patients affected by spinal metastases.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-11
• Study First Submitted QC: 2024-01-22
• Study First Posted: 2024-01-23
• Study Start: 2024-02-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 356

Inclusion Criteria

• Alive or dead
• Age 18 -99 years old
• Both male and female
• Diagnosis of cancer metastases at the spine
• Any SINS score
• Admitted for hospitalisation or outpatient visit from Jan 2012 to Dec 2022 N ≥ 1 non-stabilised metastatic vertebra
• Presence of baseline CT scan, and/or MRI and x-rays, showing the presence of metastatic lesions that are not surgically treated
• At least one follow-up visit at ≥ 3 months after the first evaluation or treatment

Exclusion Criteria

• Minor patients
• Patients with diagnosis of primary spine tumour, degenerative spinal diseases, deformity or trauma
• Patients without non-stabilised vertebral metastases
• Patients without baseline CT scan or MRI
• Patients without follow up visits

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Vertebral metastases	Case series review of clinical and radiographic data	Patients affected by spinal metastases that are not surgically treated

Primary Outcome Measures

Name	Time	Method
risk factors for vertebral fracture	through study completion, an average of 1 year	The primary objective of the study is to identify the main relevant demographic, clinical and radiographic characteristics to be used for stratifying the patients with vertebral metastases based on their risk of fracture.

Secondary Outcome Measures

Name	Time	Method
AI-based models	after 1 year	To train the data-driven computational models (METASTRA-AI) developed within the project
Critical metastases	after 1 year	To classify critical metastases
Physiology-based biomechanical models	after 1 year	To inform the physiology-based biomechanical models (METASTRA-VPH) developed within the project

Trial Locations

Locations (3)

Charite - Universitaetsmedizin Berlin; 🇩🇪 Berlin, Germany

Budai Egeszsegkozpont Zrt; 🇭🇺 Budapest, Hungary

Universitair Medisch Centrum Utrecht; 🇳🇱 Utrecht, Netherlands