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

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.

Study Overview

• Status: Recruiting
• Conditions: Bone Metastases; Neuroendocrine Neoplasm

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 Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Cristina Mazzon, Ph.D.; Phone Number: +39(0)294372686

Study Locations

• Italy
  • Milan, Italy, 20141
    • Recruiting
    • European Institute of Oncology, IEO, IRCCS
    • Sub-Investigator: Alice Laffi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with bone metastases from NENs histologically proved.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Investigators: Study Chair: Nicola Fazio, M.D., Ph.D., European Institute of Oncology, IEO, IRCCS; Principal Investigator: Francesca Spada, M.D., Ph.D., European Institute of Oncology, IEO, IRCCS

Publications and helpful links

General Publications

• Harding JJ, Abu-Zeinah G, Chou JF, Owen DH, Ly M, Lowery MA, Capanu M, Do R, Kemeny NE, O'Reilly EM, Saltz LB, Abou-Alfa GK. Frequency, Morbidity, and Mortality of Bone Metastases in Advanced Hepatocellular Carcinoma. J Natl Compr Canc Netw. 2018 Jan;16(1):50-58. doi: 10.6004/jnccn.2017.7024.
• Grisanti S, Bianchi S, Locati LD, Triggiani L, Vecchio S, Bonetta A, Bergamini C, Conte P, Airoldi M, Merlano M, Carlini P, Ibrahim T, Rossetto C, Alfieri S, Pronzato P, Tonoli S, Maroldi R, Nicolai P, Resteghini C, Magrini SM, Berruti A. Bone metastases from head and neck malignancies: Prognostic factors and skeletal-related events. PLoS One. 2019 Mar 20;14(3):e0213934. doi: 10.1371/journal.pone.0213934. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: January 20, 2021
• First Submitted That Met QC Criteria: January 20, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 20, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Neuroendocrine tumors; Bisphosphonates; NET; NEC; Neuroendocrine carcinomas
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms by Site; Hematologic Diseases; Musculoskeletal Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neoplastic Processes; Bone Diseases; Neoplasms; Neoplasm Metastasis; Bone Neoplasms; Bone Marrow Diseases; Neuroendocrine Tumors
• Other Study ID Numbers: IEO 1436

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No