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

Bone Metastases Clinical Trial

— MONET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04720391
• Other study ID #: IEO 1436
• Status: Recruiting
• Start date: January 8, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2021
• Source: European Institute of Oncology
• Contact: Darina Tamayo, PharmSc.
• Phone: +39(0)294372686
• Email: darina.tamayo[@]ieo.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Metastases
• Bone Neoplasms
• Neoplasm Metastasis
• Neoplasms
• Neuroendocrine Neoplasm
• Neuroendocrine Tumors

Locations

Country	Name	City	State
Italy	European Institute of Oncology, IEO, IRCCS	Milan

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	Overall survival (OS) will be calculated from the date of BM diagnosis to the date of death	01/2021 - 12/2021
Primary	Influence of skeletal related events (SRE) on survival	Influence of skeletal related events (SRE) on overall survival (OS)	01/2021 - 12/2021
Primary	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
Primary	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	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
Secondary	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
Secondary	Radiological diagnosis (CT, MRI)	To describe the morphological features of bone metastases in patients with NEN	01/2021 - 12/2021
Secondary	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
Secondary	Impact of antitumor therapy on bone metastases behavior	To describe the global impact of antitumor therapies on bone metastases behavior	01/2021 - 12/2021
Secondary	Impact of supportive care	To describe the global impact of supportive care on overal survival	01/2021 - 12/2021