Recruiting NCT06367491
National Database of Bone Metastases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Registration in a database.
- Who it may be relevant to
- Registry conditions: Bone Metastases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Banca Dati Nazionale Metastasi Ossee
Overview
BDMO is an Italian multicentre, observational, prospective study that collects data from all patients with bone metastases referred to each participating centre, using an on-line software 'tailor-made' for data collection.
Interventions
- Other Registration in a database
All patients with bone metastasis enrolled at the centre will be entered into the database and followed until death or interruption of follow-up for any another cause
Primary outcome measures
- The establishment of a National Bone Metastasis Database at the IRCCS IRST [Time frame: Up to 15 years]
Secondary outcome measures (6)
- Evaluation of clinical factors related to the primary tumor and metastases [Time frame: Up to 15 years]
- Evaluation of clinical factors related to the primary tumor and metastases [Time frame: Up to 15 years]
- Evaluation of clinical factors related to the primary tumor and metastases [Time frame: Up to 15 years]
- Impact of treatment on skeletal events (SRE) [Time frame: Up to 15 years]
- Analysis of overall efficiency of the mono- and multidisciplinary pathway on skeletal events (SRE) [Time frame: Up to 15 years]
- Evaluation of biological factors related to the primary tumour and metastases [Time frame: Up to 15 years]
Eligibility criteria
Inclusion criteria
- Radiological and/or histological diagnosis of bone metastasis from histologically established solid tumor
- Males or females aged >= 18 years
- Informed consent
Exclusion criteria
- Not applicable
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 30 centers
- A.U.S.L. Imola — Imola
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) — Meldola
- Osp. "Sacro Cuore di Gesù" — Gallipoli
- Osp. S. Vincenzo - ASP Messina — Taormina
- Osp. Ramazzini di Carpi - AUSL Modena — Carpi
- P.O. "S. Maria delle Grazie" — Pozzuoli
- Osp. degli Infermi — Faenza
- Ospedale Umberto I — Lugo
- … and 22 more centers
Identifiers
NCT: NCT06367491 · IRST100.12