NCT04720391

Bone Metastases in neurOendocrine NEoplasms: naTural History, Prognostic Impact and Therapeutic Approach (MONET)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: European Institute of Oncology · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a retrospective/prospective observational multicentric trial on patients with bone metastases from NENs. General objectives: * To trace on a national scale the frequency of bone metastases in patients with neuroendocrine neoplasm (NEN) and their clinical management. * To correlate clinical and biological factors to clinical outcomes. * To centralise and to make homogeneous clinical, pathological, instrumental and therapeutic information. * To set up a database and to acquire biological material for studying predictive and prognostic biomarkers.

Detailed description

Background, rationale and objectives: On March 25th 2015 the Ethical Committee from IEO approved the academic study entitled "Bone metastases in neuroendocrine tumors (NETs): a survey on natural history, prognostic value and treatment approach", version 1.0 30-Jan-2015. This was a retrospective study led to report how the issue bone metastases from NETs was handle in real practice. Preliminary data related to 321 patients from 18 Italian centers were presented as a poster at the ESMO 2017 congress (Fazio et al. 448P) and they will be included in a manuscript to submit for publication in a peer-review journal. The current protocol regards the continuation of the retrospective analysis, starting since 2014, since the previous study required data collection up to 2013, and at the same time a multicenter prospective observational analysis on the topic. Duration of the study The study will regard patients fulfilling the eligibility criteria from 2014 to 2021. Data analysis will be completed by the year 2021.

Conditions

• Bone Metastases
• Neuroendocrine Neoplasm

Timeline

• Start date: 2021-01-08
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2021-01-22
• Last updated: 2021-01-22

Locations

1 site across 1 country: Italy