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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with bone metastasis | All patients with bone metastasis |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Registration in a database | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The establishment of a National Bone Metastasis Database at the IRCCS IRST | Up to 15 years |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of clinical factors related to the primary tumor and metastases | Descriptive statistics will be calculated on the basis of the stratification factors identified at baseline assessment (age, sex, site and morphology of primary tumour, number of lesions, type of metastasis) | Up to 15 years |
| Evaluation of clinical factors related to the primary tumor and metastases |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with bone metasis in any site.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicoletta Ranallo, MD | Contact | nicoletta.ranallo@irst.emr.it | ||
| Centro di Coordinamento | Contact | cc.ubsc@irst.emr.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.U.S.L. Imola | Recruiting | Imola | Bologna | Italy |
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Overall survival will be calculated as the time between the date of diagnosis of the primary tumour and death or the end of follow-up |
| Up to 15 years |
| Evaluation of clinical factors related to the primary tumor and metastases | Disease-free interval will be calculated from the date of diagnosis of the primary tumour until the diagnosis of bone metastasis | Up to 15 years |
| Impact of treatment on skeletal events (SRE) | Time to first skeletal related events (SRE) will be calculated from the date of incidence of the bone metastasis to the date of incidence of the first SRE, regardless of the type | Up to 15 years |
| Analysis of overall efficiency of the mono- and multidisciplinary pathway on skeletal events (SRE) | The Skeletal Morbidity Rate (SMR) will be calculated by summing the SREs occurring during the observation period, for each patient | Up to 15 years |
| Evaluation of biological factors related to the primary tumour and metastases | Evaluation of site-specific receptors | Up to 15 years |
| Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) | Recruiting | Meldola | FC | 47014 | Italy |
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| Osp. "Sacro Cuore di Gesù" | Not yet recruiting | Gallipoli | Lecce | Italy |
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| Osp. S. Vincenzo - ASP Messina | Recruiting | Taormina | Messina | Italy |
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| Osp. Ramazzini di Carpi - AUSL Modena | Recruiting | Carpi | Modena | Italy |
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| P.O. "S. Maria delle Grazie" | Recruiting | Pozzuoli | Napoli | Italy |
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| Osp. degli Infermi | Recruiting | Faenza | Ravenna | Italy |
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| Ospedale Umberto I | Recruiting | Lugo | Ravenna | Italy |
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| Istituto Neurotraumatologico Italiano (INI) | Recruiting | Grottaferrata | Roma | Italy |
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| A.O.U. Ospedali Riuniti | Recruiting | Ancona | Italy |
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| Centro di Riferimento Oncologico - IRCCS CRO | Recruiting | Aviano | Italy |
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| A.O.U.C. Policlinico di Bari Osp."Giovanni XXIII" | Recruiting | Bari | Italy |
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| A.O. "S. Pio" | Recruiting | Benevento | Italy |
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| IRCCS Ist. Ortopedico Rizzoli | Recruiting | Bologna | Italy |
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| ASST Spedali Civili di Brescia | Recruiting | Brescia | Italy |
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| A.O. S. Croce e Carle | Recruiting | Cuneo | Italy |
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| A.O.U. "Arcispedale S. Anna" - AUSL Ferrara | Recruiting | Ferrara | Italy |
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| Ospedale Civile di Legnano - ASST Ovest Milanese | Recruiting | Legnano | Italy |
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| Fond. IRCCS Istituto Nazionale dei Tumori - INT | Recruiting | Milan | Italy |
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| A.O.R.N. "A. Cardarelli" | Recruiting | Naples | Italy |
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| Istituto Oncologico Veneto | Recruiting | Padova | Italy |
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| Fond. IRCCS Policlinico San Matteo | Recruiting | Pavia | Italy |
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| Osp. Guglielmo da Saliceto | Recruiting | Piacenza | Italy |
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| Osp. S. Maria delle Croci | Recruiting | Ravenna | Italy |
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| IRCCS Arcispedale S. Maria Nuova - A.O. Reggio Emilia | Recruiting | Reggio Emilia | Italy |
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| Ospedale degli Infermi | Recruiting | Rimini | Italy |
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| IRCCS Fond. Policlinico "A. Gemelli" - U.O.C. Oncologia Medica | Recruiting | Roma | Italy |
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| IRCCS Fond. Policlinico "A. Gemelli" - U.O.S. Senologia Medica / U.O.C. Ginecologia oncologica | Recruiting | Roma | Italy |
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| Ospedale di Treviglio - Caravaggio ASST Bergamo Ovest | Recruiting | Treviglio | Italy |
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| A.O.U.I. Verona | Recruiting | Verona | Italy |
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