Spinal Metastases
Conditions
Keywords
risk of fracture, spinal instability, decision support system, artificial intelligence-based models, mechanistic personalised model
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.
Interventions
OTHERCase series review of clinical and radiographic data
Extraction of clinical and radiographic data related to patients' history from medical records
Sponsors
Istituto Ortopedico Rizzoli
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| risk factors for vertebral fracture | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Critical metastases | after 1 year | To classify critical metastases |
| AI-based models | after 1 year | To train the data-driven computational models (METASTRA-AI) developed within the project |
| Physiology-based biomechanical models | after 1 year | To inform the physiology-based biomechanical models (METASTRA-VPH) developed within the project |
Countries
Germany, Hungary, Netherlands
Outcome results
None listed