Multicentric European Study In Patients With Vertebral Metastases

March 18, 2025 updated by: Istituto Ortopedico Rizzoli

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
356

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
at the baseline
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.
through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Critical metastases
Time Frame: after 1 year
To classify critical metastases
after 1 year
AI-based models
Time Frame: after 1 year
To train the data-driven computational models (METASTRA-AI) developed within the project
after 1 year
Physiology-based biomechanical models
Time Frame: after 1 year
To inform the physiology-based biomechanical models (METASTRA-VPH) developed within the project
after 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istituto Ortopedico Rizzoli

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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