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National Database of Bone Metastases

ConditionBone Metastases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Radiological and/or histological diagnosis of bone metastasis from histologically established solid tumor

Males or females aged >= 18 years

Informed consent

Disqualifiers

Not applicable

Trial population

Patients with bone metasis in any site.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Registration in a database

    Other intervention

    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

Treatment groups

800 Participants
are divided into 1 treatment group
Group A: Patients with bone metastasis1 intervention

Trial outcomes

Primary outcomes

1

The establishment of a National Bone Metastasis Database at the IRCCS IRST

Time frame
Up to 15 years

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

Lead sponsor

Source ClinicalTrials.gov
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