National Database of Bone Metastases (BDMO)

Banca Dati Nazionale Metastasi Ossee

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.

Study Overview

• Status: Recruiting
• Conditions: Bone Metastases
• Intervention / Treatment: Other: Registration in a database

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Nicoletta Ranallo, MD; Email: nicoletta.ranallo@irst.emr.it
• Study Contact Backup: Name: Centro di Coordinamento; Email: cc.ubsc@irst.emr.it

Study Locations

• Italy
  • Ancona, Italy
    • Recruiting
    • A.O.U. Ospedali Riuniti
    • Contact: Rosanna Berardi, MD
  • Aviano, Italy
    • Recruiting
    • Centro di Riferimento Oncologico - IRCCS CRO
    • Contact: Alessandro Del Conto, MD
  • Bari, Italy
    • Recruiting
    • A.O.U.C. Policlinico di Bari Osp."Giovanni XXIII"
    • Contact: Stefania Succi, MD
  • Benevento, Italy
    • Recruiting
    • A.O. "S. Pio"
    • Contact: Vincenzo Ricci, MD
  • Bologna, Italy
    • Recruiting
    • IRCCS Ist. Ortopedico Rizzoli
    • Contact: Toni Ibrahim, MD
  • Brescia, Italy
    • Recruiting
    • ASST Spedali Civili di Brescia
    • Contact: Rebecca Pedersini, MD
  • Cuneo, Italy
    • Recruiting
    • A.O. S. Croce e Carle
    • Contact: Marcella Occelli, MD
  • Ferrara, Italy
    • Recruiting
    • A.O.U. "Arcispedale S. Anna" - AUSL Ferrara
    • Contact: Antonio Frassoldati, MD
  • Legnano, Italy
    • Recruiting
    • Ospedale Civile di Legnano - ASST Ovest Milanese
    • Contact: Elena Farè, MD
  • Milano, Italy
    • Recruiting
    • Fond. IRCCS Istituto Nazionale dei Tumori - INT
    • Contact: Valentina Guadalupi, MD
  • Napoli, Italy
    • Recruiting
    • A.O.R.N. "A. Cardarelli"
    • Contact: Ferdinando Riccardi, MD
  • Padova, Italy
    • Recruiting
    • Istituto Oncologico Veneto
    • Contact: Marco Maruzzo, MD
  • Pavia, Italy
    • Recruiting
    • Fond. IRCCS Policlinico San Matteo
    • Contact: Elisa Ferraris, MD
  • Piacenza, Italy
    • Recruiting
    • Osp. Guglielmo da Saliceto
    • Contact: Luigi Cavanna, MD
  • Ravenna, Italy
    • Recruiting
    • Osp. S. Maria delle Croci
    • Contact: Enrico Campadelli, MD
  • Reggio Emilia, Italy
    • Recruiting
    • IRCCS Arcispedale S. Maria Nuova - A.O. Reggio Emilia
    • Contact: Maria Banzi, MD
  • Rimini, Italy
    • Recruiting
    • Ospedale degli Infermi
    • Contact: Manuela Fantini, MD
  • Roma, Italy
    • Recruiting
    • IRCCS Fond. Policlinico "A. Gemelli" - U.O.C. Oncologia Medica
    • Contact: Emilio Bria, MD
  • Roma, Italy
    • Recruiting
    • IRCCS Fond. Policlinico "A. Gemelli" - U.O.S. Senologia Medica / U.O.C. Ginecologia oncologica
    • Contact: Alessandra Fabi, MD
  • Treviglio, Italy
    • Recruiting
    • Ospedale di Treviglio - Caravaggio ASST Bergamo Ovest
    • Contact: Andrea Luciani, MD
  • Verona, Italy
    • Recruiting
    • A.O.U.I. Verona
    • Contact: Jessica Menis, MD
  • Bologna
    • Imola, Bologna, Italy
      • Recruiting
      • A.U.S.L. Imola
      • Contact: Antonio Maestri, MD
  • FC
    • Meldola, FC, Italy, 47014
      • Recruiting
      • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
      • Contact: Nicoletta Ranallo, MD; Phone Number: 0543739100; Email: nicoletta.ranallo@irst.emr.it
      • Sub-Investigator: Nicoletta Ranallo, MD
  • Lecce
    • Gallipoli, Lecce, Italy
      • Not yet recruiting
      • Osp. "Sacro Cuore di Gesù"
      • Contact: Rosachiara Forcignanò, MD
  • Messina
    • Taormina, Messina, Italy
      • Recruiting
      • Osp. S. Vincenzo - ASP Messina
      • Contact: Francesco Ferrarù, MD
  • Modena
    • Carpi, Modena, Italy
      • Recruiting
      • Osp. Ramazzini di Carpi - AUSL Modena
      • Contact: Fabrizio Artioli, MD
  • Napoli
    • Pozzuoli, Napoli, Italy
      • Recruiting
      • P.O. "S. Maria delle Grazie"
      • Contact: Gaetano Facchini, MD
  • Ravenna
    • Faenza, Ravenna, Italy
      • Recruiting
      • Osp. degli Infermi
      • Contact: Enrico Campadelli, MD
    • Lugo, Ravenna, Italy
      • Recruiting
      • Ospedale Umberto I
      • Contact: Enrico Campadelli, MD
  • Roma
    • Grottaferrata, Roma, Italy
      • Recruiting
      • Istituto Neurotraumatologico Italiano (INI)
      • Contact: Gaetano Lanzetta, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with bone metasis in any site.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with bone metastasis; All patients with bone metastasis	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The establishment of a National Bone Metastasis Database at the IRCCS IRST	Up to 15 years

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2013
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: IRST100.12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No