NCT06367491

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
45mo left

Started Oct 2013

Longer than P75 for all trials

Geographic Reach
1 country

30 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Oct 2013Jan 2030

Study Start

First participant enrolled

October 8, 2013

Completed
10.4 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 16, 2024

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

April 16, 2024

Status Verified

April 1, 2024

Enrollment Period

16.2 years

First QC Date

March 13, 2024

Last Update Submit

April 11, 2024

Conditions

Bone Metastases

Outcome Measures

Primary Outcomes (1)

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

    Up to 15 years

Secondary Outcomes (6)

  • Evaluation of clinical factors related to the primary tumor and metastases

    Up to 15 years

  • Evaluation of clinical factors related to the primary tumor and metastases

    Up to 15 years

  • Evaluation of clinical factors related to the primary tumor and metastases

    Up to 15 years

  • Impact of treatment on skeletal events (SRE)

    Up to 15 years

  • Analysis of overall efficiency of the mono- and multidisciplinary pathway on skeletal events (SRE)

    Up to 15 years

  • +1 more secondary outcomes

Study Arms (1)

Patients with bone metastasis

All patients with bone metastasis

Other: Registration in a database

Interventions

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

Patients with bone metastasis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with bone metasis in any site.

You may qualify if:

  • Radiological and/or histological diagnosis of bone metastasis from histologically established solid tumor
  • Males or females aged \>= 18 years
  • Informed consent

You may not qualify if:

  • Not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

A.U.S.L. Imola

Imola, Bologna, Italy

RECRUITING

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

Meldola, FC, 47014, Italy

RECRUITING

Osp. "Sacro Cuore di Gesù"

Gallipoli, Lecce, Italy

NOT YET RECRUITING

Osp. S. Vincenzo - ASP Messina

Taormina, Messina, Italy

RECRUITING

Osp. Ramazzini di Carpi - AUSL Modena

Carpi, Modena, Italy

RECRUITING

P.O. "S. Maria delle Grazie"

Pozzuoli, Napoli, Italy

RECRUITING

Osp. degli Infermi

Faenza, Ravenna, Italy

RECRUITING

Ospedale Umberto I

Lugo, Ravenna, Italy

RECRUITING

Istituto Neurotraumatologico Italiano (INI)

Grottaferrata, Roma, Italy

RECRUITING

A.O.U. Ospedali Riuniti

Ancona, Italy

RECRUITING

Centro di Riferimento Oncologico - IRCCS CRO

Aviano, Italy

RECRUITING

A.O.U.C. Policlinico di Bari Osp."Giovanni XXIII"

Bari, Italy

RECRUITING

A.O. "S. Pio"

Benevento, Italy

RECRUITING

IRCCS Ist. Ortopedico Rizzoli

Bologna, Italy

RECRUITING

ASST Spedali Civili di Brescia

Brescia, Italy

RECRUITING

A.O. S. Croce e Carle

Cuneo, Italy

RECRUITING

A.O.U. "Arcispedale S. Anna" - AUSL Ferrara

Ferrara, Italy

RECRUITING

Ospedale Civile di Legnano - ASST Ovest Milanese

Legnano, Italy

RECRUITING

Fond. IRCCS Istituto Nazionale dei Tumori - INT

Milan, Italy

RECRUITING

A.O.R.N. "A. Cardarelli"

Napoli, Italy

RECRUITING

Istituto Oncologico Veneto

Padua, Italy

RECRUITING

Fond. IRCCS Policlinico San Matteo

Pavia, Italy

RECRUITING

Osp. Guglielmo da Saliceto

Piacenza, Italy

RECRUITING

Osp. S. Maria delle Croci

Ravenna, Italy

RECRUITING

IRCCS Arcispedale S. Maria Nuova - A.O. Reggio Emilia

Reggio Emilia, Italy

RECRUITING

Ospedale degli Infermi

Rimini, Italy

RECRUITING

IRCCS Fond. Policlinico "A. Gemelli" - U.O.C. Oncologia Medica

Roma, Italy

RECRUITING

IRCCS Fond. Policlinico "A. Gemelli" - U.O.S. Senologia Medica / U.O.C. Ginecologia oncologica

Roma, Italy

RECRUITING

Ospedale di Treviglio - Caravaggio ASST Bergamo Ovest

Treviglio, Italy

RECRUITING

A.O.U.I. Verona

Verona, Italy

RECRUITING

Central Study Contacts

Nicoletta Ranallo, MD

CONTACT

nicoletta.ranallo@irst.emr.it

Centro di Coordinamento

CONTACT

cc.ubsc@irst.emr.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
20 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2024

First Posted

April 16, 2024

Study Start

October 8, 2013

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

April 16, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(30)