National Database of Bone Metastases

Bone Metastases Clinical Trial

— BDMO  

Official title:

Banca Dati Nazionale Metastasi Ossee

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06367491
• Other study ID #: IRST100.12
• Status: Recruiting
• Start date: October 8, 2013
• Est. completion date: January 1, 2030

Study information

• Verified date: April 2024
• Source: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
• Contact: Nicoletta Ranallo, MD
• Email: nicoletta.ranallo[@]irst.emr.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: January 1, 2030
• Est. primary completion date: January 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Metastases
• Neoplasm Metastasis

Intervention

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

Locations

Country	Name	City	State
Italy	A.O.U. Ospedali Riuniti	Ancona
Italy	Centro di Riferimento Oncologico - IRCCS CRO	Aviano
Italy	A.O.U.C. Policlinico di Bari Osp."Giovanni XXIII"	Bari
Italy	A.O. "S. Pio"	Benevento
Italy	IRCCS Ist. Ortopedico Rizzoli	Bologna
Italy	ASST Spedali Civili di Brescia	Brescia
Italy	Osp. Ramazzini di Carpi - AUSL Modena	Carpi	Modena
Italy	A.O. S. Croce e Carle	Cuneo
Italy	Osp. degli Infermi	Faenza	Ravenna
Italy	A.O.U. "Arcispedale S. Anna" - AUSL Ferrara	Ferrara
Italy	Osp. "Sacro Cuore di Gesù"	Gallipoli	Lecce
Italy	Istituto Neurotraumatologico Italiano (INI)	Grottaferrata	Roma
Italy	A.U.S.L. Imola	Imola	Bologna
Italy	Ospedale Civile di Legnano - ASST Ovest Milanese	Legnano
Italy	Ospedale Umberto I	Lugo	Ravenna
Italy	Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)	Meldola	FC
Italy	Fond. IRCCS Istituto Nazionale dei Tumori - INT	Milano
Italy	A.O.R.N. "A. Cardarelli"	Napoli
Italy	Istituto Oncologico Veneto	Padova
Italy	Fond. IRCCS Policlinico San Matteo	Pavia
Italy	Osp. Guglielmo da Saliceto	Piacenza
Italy	P.O. "S. Maria delle Grazie"	Pozzuoli	Napoli
Italy	Osp. S. Maria delle Croci	Ravenna
Italy	IRCCS Arcispedale S. Maria Nuova - A.O. Reggio Emilia	Reggio Emilia
Italy	Ospedale degli Infermi	Rimini
Italy	IRCCS Fond. Policlinico "A. Gemelli" - U.O.C. Oncologia Medica	Roma
Italy	IRCCS Fond. Policlinico "A. Gemelli" - U.O.S. Senologia Medica / U.O.C. Ginecologia oncologica	Roma
Italy	Osp. S. Vincenzo - ASP Messina	Taormina	Messina
Italy	Ospedale di Treviglio - Caravaggio ASST Bergamo Ovest	Treviglio
Italy	A.O.U.I. Verona	Verona

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The establishment of a National Bone Metastasis Database at the IRCCS IRST		Up to 15 years
Secondary	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
Secondary	Evaluation of clinical factors related to the primary tumor and metastases	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Evaluation of biological factors related to the primary tumour and metastases	Evaluation of site-specific receptors	Up to 15 years