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Completed

NCT Number: NCT06220071

Multicentric European Study In Patients With Vertebral Metastases

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.

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Key information

Conditions

Spinal Metastases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Charite - Universitaetsmedizin Berlin, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Case series review of clinical and radiographic data

Other

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

Primary outcomes

  1. risk factors for vertebral fracture

    Time frame: at the baseline

    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.

  2. risk factors for vertebral fracture

    Time frame: 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 outcomes

  1. Critical metastases

    Time frame: after 1 year

    To classify critical metastases

  2. AI-based models

    Time frame: after 1 year

    To train the data-driven computational models (METASTRA-AI) developed within the project

  3. Physiology-based biomechanical models

    Time frame: after 1 year

    To inform the physiology-based biomechanical models (METASTRA-VPH) developed within the project

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 23, 2024
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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