Spinal MetastasesNCT06220071
Multicentric European Study In Patients With Vertebral Metastases
An observational study of Spinal Metastases, run by Istituto Ortopedico Rizzoli at 3 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Metastases
- What is being tested?
- Case series review of clinical and radiographic data
- How many people
- 356 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Feb 2024to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: 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.
- Conditions
- Spinal Metastases
- Being tested
- Case series review of clinical and radiographic data
- Keywords
- risk of fracture, spinal instability, decision support system, artificial intelligence-based models, mechanistic personalised model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case series review of clinical and radiographic dataOther
Extraction of clinical and radiographic data related to patients' history from medical records
| Study group | Role | What they receive |
|---|---|---|
| Vertebral metastases | Patients affected by spinal metastases that are not surgically treated Receives: Other: Case series review of clinical and radiographic data |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Critical metastases
To classify critical metastases
Measured: after 1 year
AI-based models
To train the data-driven computational models (METASTRA-AI) developed within the project
Measured: after 1 year
Physiology-based biomechanical models
To inform the physiology-based biomechanical models (METASTRA-VPH) developed within the project
Measured: after 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start1 Feb 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal MetastasesStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220071
- Sponsor's protocol ID
- Train-METASTRA
- Status last verified
- Mar 2025
- First submitted
- 11 Jan 2024
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Multicentric European Study In Patients With Vertebral Metastases (Train-Metastra)
- ClinicalTrials.gov ID
- NCT06220071
- Acronym / sponsor ID
- Train-METASTRA
- Conditions
- Spinal Metastases
- Keywords
- risk of fracture, spinal instability, decision support system, artificial intelligence-based models, mechanistic personalised model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vertebral metastases | – | Other: Case series review of clinical and radiographic dataPatients affected by spinal metastases that are not surgically treated |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- Alive or dead
- Age 18 -99 years old
- Both male and female
- Diagnosis of cancer metastases at the spine
- Any SINS score
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Case series review of clinical and radiographic dataExtraction of clinical and radiographic data related to patients' history from medical records | Other | Vertebral metastases |
Primary outcome
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.
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.
3 secondary outcomes
Critical metastases
Time frame: after 1 year
AI-based models
Time frame: after 1 year
Physiology-based biomechanical models
Time frame: after 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Metastases, run by Istituto Ortopedico Rizzoli at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Hungary, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
risk factors for vertebral fracture (time frame: at the baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.