Clinical trial NCT06367491: National Database of Bone Metastases
Official title: Banca Dati Nazionale Metastasi Ossee
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bone Metastases
Lead sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with bone metasis in any site.

Brief summary: 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.


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

Primary outcomes:
measure: The establishment of a National Bone Metastasis Database at the IRCCS IRST
timeFrame: Up to 15 years
Secondary outcomes:
measure: Evaluation of clinical factors related to the primary tumor and metastases
timeFrame: Up to 15 years
measure: Evaluation of clinical factors related to the primary tumor and metastases
timeFrame: Up to 15 years
measure: Evaluation of clinical factors related to the primary tumor and metastases
timeFrame: Up to 15 years
measure: Impact of treatment on skeletal events (SRE)
timeFrame: Up to 15 years
measure: Analysis of overall efficiency of the mono- and multidisciplinary pathway on skeletal events (SRE)
timeFrame: Up to 15 years
measure: Evaluation of biological factors related to the primary tumour and metastases
timeFrame: Up to 15 years
Other outcomes:
Locations:
city: Imola
country: Italy
facility: A.U.S.L. Imola
state: Bologna
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
state: FC
city: Gallipoli
country: Italy
facility: Osp. "Sacro Cuore di Gesù"
state: Lecce
city: Taormina
country: Italy
facility: Osp. S. Vincenzo - ASP Messina
state: Messina
city: Carpi
country: Italy
facility: Osp. Ramazzini di Carpi - AUSL Modena
state: Modena
city: Pozzuoli
country: Italy
facility: P.O. "S. Maria delle Grazie"
state: Napoli
city: Faenza
country: Italy
facility: Osp. degli Infermi
state: Ravenna
city: Lugo
country: Italy
facility: Ospedale Umberto I
state: Ravenna
city: Grottaferrata
country: Italy
facility: Istituto Neurotraumatologico Italiano (INI)
state: Roma
city: Ancona
country: Italy
facility: A.O.U. Ospedali Riuniti
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico - IRCCS CRO
city: Bari
country: Italy
facility: A.O.U.C. Policlinico di Bari Osp."Giovanni XXIII"
city: Benevento
country: Italy
facility: A.O. "S. Pio"
city: Bologna
country: Italy
facility: IRCCS Ist. Ortopedico Rizzoli
city: Brescia
country: Italy
facility: ASST Spedali Civili di Brescia
city: Cuneo
country: Italy
facility: A.O. S. Croce e Carle
city: Ferrara
country: Italy
facility: A.O.U. "Arcispedale S. Anna" - AUSL Ferrara
city: Legnano
country: Italy
facility: Ospedale Civile di Legnano - ASST Ovest Milanese
city: Milano
country: Italy
facility: Fond. IRCCS Istituto Nazionale dei Tumori - INT
city: Napoli
country: Italy
facility: A.O.R.N. "A. Cardarelli"
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
city: Pavia
country: Italy
facility: Fond. IRCCS Policlinico San Matteo
city: Piacenza
country: Italy
facility: Osp. Guglielmo da Saliceto
city: Ravenna
country: Italy
facility: Osp. S. Maria delle Croci
city: Reggio Emilia
country: Italy
facility: IRCCS Arcispedale S. Maria Nuova - A.O. Reggio Emilia
city: Rimini
country: Italy
facility: Ospedale degli Infermi
city: Roma
country: Italy
facility: IRCCS Fond. Policlinico "A. Gemelli" - U.O.C. Oncologia Medica
city: Roma
country: Italy
facility: IRCCS Fond. Policlinico "A. Gemelli" - U.O.S. Senologia Medica / U.O.C. Ginecologia oncologica
city: Treviglio
country: Italy
facility: Ospedale di Treviglio - Caravaggio ASST Bergamo Ovest
city: Verona
country: Italy
facility: A.O.U.I. Verona
Study officials:
References: