National Database of Bone Metastases

Recruiting

• Conditions: Bone Metastases

• Registration Number: NCT06367491
• Lead Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-08
• Study First Submitted: 2024-03-13
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-11
• Last Update Submitted: 2024-04-11
• Study First Posted: 2024-04-16
• Last Update Posted: 2024-04-16
• Primary Completion: 2030-01-01
• Study Completion: 2030-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The establishment of a National Bone Metastasis Database at the IRCCS IRST	Up to 15 years

Secondary Outcome Measures

Name	Time	Method
Evaluation of biological factors related to the primary tumour and metastases	Up to 15 years	Evaluation of site-specific receptors
Evaluation of clinical factors related to the primary tumor and metastases	Up to 15 years	Disease-free interval will be calculated from the date of diagnosis of the primary tumour until the diagnosis of bone metastasis
Impact of treatment on skeletal events (SRE)	Up to 15 years	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
Analysis of overall efficiency of the mono- and multidisciplinary pathway on skeletal events (SRE)	Up to 15 years	The Skeletal Morbidity Rate (SMR) will be calculated by summing the SREs occurring during the observation period, for each patient

Trial Locations

Locations (30)

A.U.S.L. Imola; 🇮🇹 Imola, Bologna, Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST); 🇮🇹 Meldola, FC, Italy

Osp. "Sacro Cuore di Gesù"; 🇮🇹 Gallipoli, Lecce, Italy

Osp. S. Vincenzo - ASP Messina; 🇮🇹 Taormina, Messina, Italy

Osp. Ramazzini di Carpi - AUSL Modena; 🇮🇹 Carpi, Modena, Italy

P.O. "S. Maria delle Grazie"; 🇮🇹 Pozzuoli, Napoli, Italy

Osp. degli Infermi; 🇮🇹 Faenza, Ravenna, Italy

Ospedale Umberto I; 🇮🇹 Lugo, Ravenna, Italy

Istituto Neurotraumatologico Italiano (INI); 🇮🇹 Grottaferrata, Roma, Italy

A.O.U. Ospedali Riuniti; 🇮🇹 Ancona, Italy

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