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

• Conditions: Bone Metastases; Neuroendocrine Neoplasm

• Registration Number: NCT04720391
• Lead Sponsor: European Institute of Oncology

Brief 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.

Study Timeline

• Status Verified: 2021-01
• Study Start: 2021-01-08
• Study First Submitted: 2021-01-20
• Study First Submitted QC: 2021-01-20
• Last Update Submitted: 2021-01-20
• Study First Posted: 2021-01-22
• Last Update Posted: 2021-01-22
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	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
Overall survival	01/2021 - 12/2021	Overall survival (OS) will be calculated from the date of BM diagnosis to the date of death
Influence of skeletal related events (SRE) on survival	01/2021 - 12/2021	Influence of skeletal related events (SRE) on overall survival (OS)
Influence of the use of bisphosphonates or RANK-ligands	01/2021 - 12/2021	To evaluate the influence of the use of bisphosphonates or RANK-ligands on overall survival

Secondary Outcome Measures

Name	Time	Method
Correlation from bone metastases and age, gender, primary site, Ki-67, grade of differentiation	01/2021 - 12/2021	To evaluate the correlation between bone metastases and patients and tumor's features
Impact of antitumor therapy on bone metastases behavior	01/2021 - 12/2021	To describe the global impact of antitumor therapies on bone metastases behavior
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	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
Impact of supportive care	01/2021 - 12/2021	To describe the global impact of supportive care on overal survival
Radiological diagnosis (CT, MRI)	01/2021 - 12/2021	To describe the morphological features of bone metastases in patients with NEN
Functional diagnosis (68GaPET/CT-DOTA-peptide, 18FDGPET/CT)	01/2021 - 12/2021	To To describe the functional features of bone metastases in patients with NEN

Trial Locations

Locations (1)

European Institute of Oncology, IEO, IRCCS; 🇮🇹 Milan, Italy