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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bone Metastases, Neuroendocrine Neoplasm

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological diagnosis of NEN Instrumental and/or histological diagnosis of bone metastasis At least one year of follow-up from the diagnosis of bone metastasis Exclusion Criteria: Small cell lung carcinoma MiNEN Non neuroendocrine neoplasm
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Overall survival (OS) will be calculated from the date of BM diagnosis to the date of death | 01/2021 - 12/2021 | 
| Influence of skeletal related events (SRE) on survival | Influence of skeletal related events (SRE) on overall survival (OS) | 01/2021 - 12/2021 | 
| Correlation between SRE and time from bone metastasis and SRE, site of one metastases, number of bone metastases, morphology of bone metastases, LDH | To evaluate the correlation between SRE and time from bone metastasis and SRE, site of one metastases, number of bone metastases, morphology of bone metastases, LDH | 01/2021 - 12/2021 | 
| Influence of the use of bisphosphonates or RANK-ligands | To evaluate the influence of the use of bisphosphonates or RANK-ligands on overall survival | 01/2021 - 12/2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation from bone metastases and age, gender, primary site, Ki-67, grade of differentiation | To evaluate the correlation between bone metastases and patients and tumor's features | 01/2021 - 12/2021 | 
| Natural history (time between diagnosis of NEN and first diagnosis of bone metastasis, frequency and time to SRE, sites of bone metastases) | To describe the natural history time between diagnosis of NEN and first diagnosis of bone metastasis, frequency and time to SRE, sites of bone metastases | 01/2021 - 12/2021 | 
| Radiological diagnosis (CT, MRI) | To describe the morphological features of bone metastases in patients with NEN | 01/2021 - 12/2021 | 
| Functional diagnosis (68GaPET/CT-DOTA-peptide, 18FDGPET/CT) | To To describe the functional features of bone metastases in patients with NEN | 01/2021 - 12/2021 | 
| Impact of antitumor therapy on bone metastases behavior | To describe the global impact of antitumor therapies on bone metastases behavior | 01/2021 - 12/2021 | 
| Impact of supportive care | To describe the global impact of supportive care on overal survival | 01/2021 - 12/2021 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NET, NEC, Neuroendocrine tumors, Neuroendocrine carcinomas, Bisphosphonates