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NCT06910618: Valid-METASTRA
A Multicenter Prospective Observational Study on Vertebral Fracture Risk Stratification in Patients With Vertebral Metastases
trial in Vertebral Metastases in 300 participants. Not yet recruiting.
1 April 2027
Quick facts
| Lead sponsor | Buda Health Center |
|---|---|
| Status | Not yet recruiting |
| Study type | OBSERVATIONAL |
| Enrollment | 300 |
| Start date | 1 April 2025 |
| Primary completion | 1 April 2027 |
| Estimated completion | 1 August 2027 |
| Sites | 4 locations across Italy, Netherlands, Germany, Hungary |
Conditions studied
- Vertebral Metastases — all drugs for Vertebral Metastases →
- Vertebral Fracture — all drugs for Vertebral Fracture →
Sponsor
Buda Health Center
Who can join
18 and older, any sex, with Vertebral Metastases or Vertebral Fracture. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Vertebral fracture is a common clinically significant skeletal related event in cancer patients. Stratification of patients diagnosed with one or more vertebral metastases according to the risk of pathological fracture is an unresolved problem despite the fact that fractures strongly influence the quality of life (QoL) and also the overall survival. The multidimensional nature and the strong patient specificity of the risk for fracture have not been considered in previously published risk estimation models and these methods were developed and validated only on retrospective data focusing on prevalence of life-time fracture which is not really relevant at the time of the diagnosis of a vertebral metastasis. To overcome these shortcomings, the METASTRA models (METASTRA-AI and METASTRA-VPH) and the decision support system (METASTRA-DSS) are developed considering the highest possible level of patient specificity to stratify the individuals according to their risk for fracture in a clinically considerable period (within next 6 months). The prospective data collection and analysis will provide reliability and validity results on the performance of METASTRA tools as well as structured information on user's experience helping the future integration of the developed patient-specific stratification tool into the everyday clinical practice. The study is a prospective clinical data collection from minimum 200 patients to determine the validity (i.e. Precision) in fracture risk stratification of the METASTRA-AI and METASTRA-VPH computational models and to determine the reliability of METASTRA-AI and METASTRA-VPH as well as human decision making process in patient stratification.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06910618
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06910618 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Buda Health Center
- Last refreshed: 4 April 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06910618.
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