Clinical trial NCT04720391: Bone Metastases in neurOendocrine NEoplasms: naTural History, Prognostic Impact and Therapeutic Approach (MONET)
Official title: Bone Metastases in neurOendocrine NEoplasms: naTural History, Prognostic Impact and Therapeutic Approach (MONET)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bone Metastases
Neuroendocrine Neoplasm
Keywords: NET
NEC
Neuroendocrine tumors
Neuroendocrine carcinomas
Bisphosphonates
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with bone metastases from NENs histologically proved.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall survival
timeFrame: 01/2021 - 12/2021
measure: Influence of skeletal related events (SRE) on survival
timeFrame: 01/2021 - 12/2021
measure: Correlation between SRE and time from bone metastasis and SRE, site of one metastases, number of bone metastases, morphology of bone metastases, LDH
timeFrame: 01/2021 - 12/2021
measure: Influence of the use of bisphosphonates or RANK-ligands
timeFrame: 01/2021 - 12/2021
Secondary outcomes:
measure: Correlation from bone metastases and age, gender, primary site, Ki-67, grade of differentiation
timeFrame: 01/2021 - 12/2021
measure: Natural history (time between diagnosis of NEN and first diagnosis of bone metastasis, frequency and time to SRE, sites of bone metastases)
timeFrame: 01/2021 - 12/2021
measure: Radiological diagnosis (CT, MRI)
timeFrame: 01/2021 - 12/2021
measure: Functional diagnosis (68GaPET/CT-DOTA-peptide, 18FDGPET/CT)
timeFrame: 01/2021 - 12/2021
measure: Impact of antitumor therapy on bone metastases behavior
timeFrame: 01/2021 - 12/2021
measure: Impact of supportive care
timeFrame: 01/2021 - 12/2021
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology, IEO, IRCCS
Study officials:
affiliation: European Institute of Oncology, IEO, IRCCS
name: Nicola Fazio, M.D., Ph.D.
role: STUDY_CHAIR
affiliation: European Institute of Oncology, IEO, IRCCS
name: Francesca Spada, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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):50-58. doi: 10.6004/jnccn.2017.7024.
citation: 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.