Multicentric European Study In Patients With Vertebral Metastases

Retrospective Multicentric European Study In Patients With Vertebral Metastases (Train-Metastra)

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.

Study Overview

• Status: Completed
• Conditions: Spinal Metastases
• Intervention / Treatment: Other: Case series review of clinical and radiographic data

• Study Type: Observational
• Enrollment (Actual): 356

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Charite - Universitaetsmedizin Berlin
• Hungary
  • Budapest, Hungary
    • Budai Egeszsegkozpont Zrt
• Netherlands
  • Utrecht, Netherlands
    • Universitair Medisch Centrum Utrecht

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The expected study population is a cohort of patients affected by spinal metastases admitted in the last ten years (from 2012 to 2022) in the four clinical centers involved in the study. This cohort of patients is characterised by the presence of one or more vertebral metastatic lesions that are not surgically treated.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vertebral metastases; Patients affected by spinal metastases that are not surgically treated	Other: Case series review of clinical and radiographic data; Extraction of clinical and radiographic data related to patients' history from medical records

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
risk factors for vertebral fracture	The primary objective of the study is to identify the main relevant characteristics to be used for stratifying the patients with vertebral metastases based on their risk of fracture.	at the baseline
risk factors for vertebral fracture	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.	through study completion, an average of 1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: January 11, 2024
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: decision support system; risk of fracture; spinal instability; artificial intelligence-based models; mechanistic personalised model
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: Train-METASTRA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No