An observational study in Bone Metastases, sponsored by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS. Recruiting at 30 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-16.
Sponsored by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Observational
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.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 885 are open to participants now.
This study's planned enrollment of 800 is above the median of 121 across 594 observational studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS is the lead sponsor of 59 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with bone metasis in any site.
Exclusion Criteria:
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
The establishment of a National Bone Metastasis Database at the IRCCS IRST
Time frame: Up to 15 years
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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 15 years
Evaluation of biological factors related to the primary tumour and metastases
Evaluation of site-specific receptors
Time frame: Up to 15 years
Plan to share: No
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Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS