Multicentric European Study In Patients With Vertebral Metastases

Spinal Metastases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06220071
• Other study ID #: Train-METASTRA
• Status: Not yet recruiting
• Start date: June 2024
• Est. completion date: February 2025

Study information

• Verified date: April 2024
• Source: Istituto Ortopedico Rizzoli
• Contact: Giovanni Barbanti Brodano, MD
• Phone: +390516366130
• Email: giovanni[@]barbantibrodano.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: February 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Spinal Metastases

Intervention

Other:
• Case series review of clinical and radiographic data
Extraction of clinical and radiographic data related to patients' history from medical records

Locations

Country	Name	City	State
Germany	Charite - Universitaetsmedizin Berlin	Berlin
Hungary	Budai Egeszsegkozpont Zrt	Budapest
Netherlands	Universitair Medisch Centrum Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Countries where clinical trial is conducted

Germany,  Hungary,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Critical metastases	To classify critical metastases	after 1 year
Secondary	AI-based models	To train the data-driven computational models (METASTRA-AI) developed within the project	after 1 year
Secondary	Physiology-based biomechanical models	To inform the physiology-based biomechanical models (METASTRA-VPH) developed within the project	after 1 year