Bone Metastases
Conditions
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.
Interventions
OTHERRegistration 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
Sponsors
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The establishment of a National Bone Metastasis Database at the IRCCS IRST | Up to 15 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of clinical factors related to the primary tumor and metastases | 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) |
| 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 |
| Evaluation of biological factors related to the primary tumour and metastases | Up to 15 years | Evaluation of site-specific receptors |
Countries
Italy
Contacts
Primary ContactNicoletta Ranallo, MD
Backup ContactCentro di Coordinamento
Outcome results
None listed