CClinicalTrials.gg
Sign In
Status unknownNCT04720391MONETUpdated Jan 22, 2021

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

An observational study in Bone Metastases and Neuroendocrine Neoplasm, sponsored by European Institute of Oncology. Status unknown at 1 site in Italy. Per ClinicalTrials.gov, last updated 2021-01-22.

Sponsored by European Institute of Oncology · Observational

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
500
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Bone Metastases
  • Neuroendocrine Neoplasm

Keywords

  • NET
  • NEC
  • Neuroendocrine tumors
  • Neuroendocrine carcinomas
  • Bisphosphonates
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 500 is above the median of 204 across 1,683 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

European Institute of Oncology is the lead sponsor of 178 studies on the registry; 113 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with bone metastases from NENs histologically proved.

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

Exclusion Criteria:

  • Small cell lung carcinoma
  • MiNEN
  • Non neuroendocrine neoplasm
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
500 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. Overall survival

    Overall survival (OS) will be calculated from the date of BM diagnosis to the date of death

    Time frame: 01/2021 - 12/2021

  2. Influence of skeletal related events (SRE) on survival

    Influence of skeletal related events (SRE) on overall survival (OS)

    Time frame: 01/2021 - 12/2021

  3. 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

    Time frame: 01/2021 - 12/2021

  4. Influence of the use of bisphosphonates or RANK-ligands

    To evaluate the influence of the use of bisphosphonates or RANK-ligands on overall survival

    Time frame: 01/2021 - 12/2021

Secondary outcomes

  1. 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

    Time frame: 01/2021 - 12/2021

  2. 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

    Time frame: 01/2021 - 12/2021

  3. Radiological diagnosis (CT, MRI)

    To describe the morphological features of bone metastases in patients with NEN

    Time frame: 01/2021 - 12/2021

  4. Functional diagnosis (68GaPET/CT-DOTA-peptide, 18FDGPET/CT)

    To To describe the functional features of bone metastases in patients with NEN

    Time frame: 01/2021 - 12/2021

  5. Impact of antitumor therapy on bone metastases behavior

    To describe the global impact of antitumor therapies on bone metastases behavior

    Time frame: 01/2021 - 12/2021

  6. Impact of supportive care

    To describe the global impact of supportive care on overal survival

    Time frame: 01/2021 - 12/2021

07

Study locations

1 of 1 sites recruiting
  • European Institute of Oncology, IEO, IRCCS
    Milan, 20141, Italy
    • Darina Tamayo, PharmSc. · Contact · darina.tamayo@ieo.it · +39(0)294372686
    • Cristina Mazzon, Ph.D. · Contact · cristina.mazzon@ieo.it · +39(0)294372686
    • Alice Laffi, MD · Sub investigator
    • Manila Rubino, MD · Sub investigator
    Recruiting
08

References and documents

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. PubMed 29295881 ↗
  • 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. PubMed 30893350 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04720391
Lead sponsor
European Institute of Oncology
Responsible party
Sponsor
First posted
Jan 22, 2021
Start date
Jan 8, 2021
Primary completion
Dec 31, 2021 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Jan 22, 2021

Study contacts

Darina Tamayo, PharmSc.
Contact
darina.tamayo@ieo.it
+39(0)294372686
Cristina Mazzon, Ph.D.
Contact
+39(0)294372686
Nicola Fazio, M.D., Ph.D.
study chair · European Institute of Oncology, IEO, IRCCS
Francesca Spada, M.D., Ph.D.
principal investigator · European Institute of Oncology, IEO, IRCCS

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Neoplasms→

Other studies from this sponsor

European Institute of Oncology

Start the discussion