Multicentric European Study In Patients With Vertebral Metastases

NCT06220071 | Completed DMC

• 1 other identifier: Train-METASTRA
• Study Type: observational
• Target: 356
• Locations: 3 countries
• Sites: 3

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.

Conditions

Spinal Metastases

Keywords

risk of fracture; spinal instability; decision support system; artificial intelligence-based models; mechanistic personalised model

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Critical metastases

  after 1 year

• AI-based models

  after 1 year

• Physiology-based biomechanical models

  after 1 year

Study Arms (1)

Vertebral metastases

Patients affected by spinal metastases that are not surgically treated

Other: Case series review of clinical and radiographic data

Interventions

Case series review of clinical and radiographic data OTHER

Extraction of clinical and radiographic data related to patients' history from medical records

Vertebral metastases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (3)

Charite - Universitaetsmedizin Berlin

Berlin, Germany

Location

Budai Egeszsegkozpont Zrt

Budapest, Hungary

Location

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 23, 2024
• Study Start: February 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

HU (1); DE (1); NL (1)