Bone MetastasesBDMONCT06367491
National Database of Bone Metastases
An observational study of Bone Metastases, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 30 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Metastases
- What is being tested?
- Registration in a database
- How many people
- 800 participants
- Where
- 30 sitesItaly
- Study dates
- 8 Oct 2013to 1 Jan 2030
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with bone metasis in any site.
Who may be able to join
- Radiological and/or histological diagnosis of bone metastasis from histologically established solid tumor
- Males or females aged >= 18 years
- Informed consent
Who cannot join
- Not applicable
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Nicoletta Ranallo, MD contact
Centro di Coordinamento contact
30 sites in 1 country
Italy30 sites, 30 recruiting
- Recruiting
A.O.U. Ospedali Riuniti
Ancona
Rosanna Berardi, MD
- Recruiting
Centro di Riferimento Oncologico - IRCCS CRO
Aviano
Alessandro Del Conto, MD
- Recruiting
A.O.U.C. Policlinico di Bari Osp."Giovanni XXIII"
Bari
Stefania Succi, MD
- Recruiting
A.O. "S. Pio"
Benevento
Vincenzo Ricci, MD
- Recruiting
IRCCS Ist. Ortopedico Rizzoli
Bologna
Toni Ibrahim, MD
- Recruiting
ASST Spedali Civili di Brescia
Brescia
Rebecca Pedersini, MD
- Recruiting
Osp. Ramazzini di Carpi - AUSL Modena
Carpi, Modena
Fabrizio Artioli, MD
- Recruiting
A.O. S. Croce e Carle
Cuneo
Marcella Occelli, MD
- Recruiting
Osp. degli Infermi
Faenza, Ravenna
Enrico Campadelli, MD
- Recruiting
A.O.U. "Arcispedale S. Anna" - AUSL Ferrara
Ferrara
Antonio Frassoldati, MD
- Not yet recruiting
Osp. "Sacro Cuore di Gesù"
Gallipoli, Lecce
Rosachiara Forcignanò, MD
- Recruiting
Istituto Neurotraumatologico Italiano (INI)
Grottaferrata, Roma
Gaetano Lanzetta, MD
- Recruiting
A.U.S.L. Imola
Imola, Bologna
Antonio Maestri, MD
- Recruiting
Ospedale Civile di Legnano - ASST Ovest Milanese
Legnano
Elena Farè, MD
- Recruiting
Ospedale Umberto I
Lugo, Ravenna
Enrico Campadelli, MD
- Recruiting
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)
Meldola, FC, 47014
Nicoletta Ranallo, MD, 0543739100, nicoletta.ranallo@irst.emr.it
Nicoletta Ranallo, MD
- Recruiting
Fond. IRCCS Istituto Nazionale dei Tumori - INT
Milan
Valentina Guadalupi, MD
- Recruiting
A.O.R.N. "A. Cardarelli"
Naples
Ferdinando Riccardi, MD
- Recruiting
Istituto Oncologico Veneto
Padova
Marco Maruzzo, MD
- Recruiting
Fond. IRCCS Policlinico San Matteo
Pavia
Elisa Ferraris, MD
- Recruiting
Osp. Guglielmo da Saliceto
Piacenza
Luigi Cavanna, MD
- Recruiting
P.O. "S. Maria delle Grazie"
Pozzuoli, Napoli
Gaetano Facchini, MD
- Recruiting
Osp. S. Maria delle Croci
Ravenna
Enrico Campadelli, MD
- Recruiting
IRCCS Arcispedale S. Maria Nuova - A.O. Reggio Emilia
Reggio Emilia
Maria Banzi, MD
- Recruiting
Ospedale degli Infermi
Rimini
Manuela Fantini, MD
- Recruiting
IRCCS Fond. Policlinico "A. Gemelli" - U.O.C. Oncologia Medica
Roma
Emilio Bria, MD
- Recruiting
IRCCS Fond. Policlinico "A. Gemelli" - U.O.S. Senologia Medica / U.O.C. Ginecologia oncologica
Roma
Alessandra Fabi, MD
- Recruiting
Osp. S. Vincenzo - ASP Messina
Taormina, Messina
Francesco Ferrarù, MD
- Recruiting
Ospedale di Treviglio - Caravaggio ASST Bergamo Ovest
Treviglio
Andrea Luciani, MD
- Recruiting
A.O.U.I. Verona
Verona
Jessica Menis, MD
About this study
Official title: 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.
- Conditions
- Bone Metastases
- Being tested
- Registration in a database
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Registration in a databaseOther
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
| Study group | Role | What they receive |
|---|---|---|
| Patients with bone metastasis | All patients with bone metastasis Receives: Other: Registration in a database |
What is being measured
The primary outcome is the main question the study is designed to answer.
The establishment of a National Bone Metastasis Database at the IRCCS IRST
Measured: Up to 15 years
Secondary outcomes (6)
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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 15 years
Evaluation of biological factors related to the primary tumour and metastases
Evaluation of site-specific receptors
Measured: Up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start8 Oct 2013
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367491
- Sponsor's protocol ID
- IRST100.12
- Acronym
- BDMO
- Status last verified
- Apr 2024
- First submitted
- 13 Mar 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Banca Dati Nazionale Metastasi Ossee
- ClinicalTrials.gov ID
- NCT06367491
- Acronym / sponsor ID
- BDMO / IRST100.12
- Conditions
- Bone Metastases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Study start
- 8 Oct 2013 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with bone metastasis | – | Other: Registration in a databaseAll patients with bone metastasis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with bone metasis in any site.
Key inclusion criteria (3 listed)
- Radiological and/or histological diagnosis of bone metastasis from histologically established solid tumor
- Males or females aged >= 18 years
- Informed consent
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Registration in a databaseAll 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 | Other | Patients with bone metastasis |
Primary outcome
The establishment of a National Bone Metastasis Database at the IRCCS IRST
Time frame: Up to 15 years
6 secondary outcomes
Evaluation of clinical factors related to the primary tumor and metastases
Time frame: Up to 15 years
Evaluation of clinical factors related to the primary tumor and metastases
Time frame: Up to 15 years
Evaluation of clinical factors related to the primary tumor and metastases
Time frame: Up to 15 years
Impact of treatment on skeletal events (SRE)
Time frame: Up to 15 years
Analysis of overall efficiency of the mono- and multidisciplinary pathway on skeletal events (SRE)
Time frame: Up to 15 years
Evaluation of biological factors related to the primary tumour and metastases
Time frame: Up to 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicoletta Ranallo, MD contact
Centro di Coordinamento contact
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Metastases, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 30 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicoletta Ranallo, MD (nicoletta.ranallo@irst.emr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The establishment of a National Bone Metastasis Database at the IRCCS IRST (time frame: Up to 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.