Bone Metastases in neurOendocrine NEoplasms: naTural History, Prognostic Impact and Therapeutic Approach (MONET)
NCT ID: NCT04720391
Last Updated: 2021-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2021-01-08
2021-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
OTHER
Eligibility Criteria
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Inclusion Criteria
* Instrumental and/or histological diagnosis of bone metastasis
* At least one year of follow-up from the diagnosis of bone metastasis
Exclusion Criteria
* MiNEN
* Non neuroendocrine neoplasm
ALL
No
Sponsors
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European Institute of Oncology
OTHER
Responsible Party
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Principal Investigators
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Nicola Fazio, M.D., Ph.D.
Role: STUDY_CHAIR
European Institute of Oncology, IEO, IRCCS
Francesca Spada, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
European Institute of Oncology, IEO, IRCCS
Locations
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European Institute of Oncology, IEO, IRCCS
Milan, , Italy
Countries
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Central Contacts
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Cristina Mazzon, Ph.D.
Role: CONTACT
Facility Contacts
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References
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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.
Other Identifiers
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IEO 1436
Identifier Type: -
Identifier Source: org_study_id
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