National Database of Bone Metastases (BDMO)

April 11, 2024 updated by: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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:
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The establishment of a National Bone Metastasis Database at the IRCCS IRST
Time Frame: Up to 15 years
Up to 15 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluation of clinical factors related to the primary tumor and metastases
Time Frame: Up to 15 years
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
Time Frame: Up to 15 years
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
Time Frame: 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
Up to 15 years
Impact of treatment on skeletal events (SRE)
Time Frame: 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
Up to 15 years
Analysis of overall efficiency of the mono- and multidisciplinary pathway on skeletal events (SRE)
Time Frame: Up to 15 years
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
Time Frame: Up to 15 years
Evaluation of site-specific receptors
Up to 15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 8, 2013

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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