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NCT Number: NCT06367491

National Database of Bone Metastases

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.

Recruiting

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Key information

Conditions

Bone Metastases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

A.U.S.L. Imola, Imola, Bologna, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Registration in a database

Other

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

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

    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)

  2. 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

  3. 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

  4. 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

  5. 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

  6. Evaluation of biological factors related to the primary tumour and metastases

    Time frame: Up to 15 years

    Evaluation of site-specific receptors

Study contacts

Contact information is provided by the study sponsor or research team.

Centro di Coordinamento

CONTACT

[email protected]

Nicoletta Ranallo, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Banca Dati Nazionale Metastasi Ossee

Acronym: BDMO

Important dates

Study start
2013
Primary completion
2030
Study completion
2030
First posted
Apr 16, 2024
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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