Bone MetastasesMONETNCT04720391
Bone Metastases in neurOendocrine NEoplasms: naTural History, Prognostic Impact and Therapeutic Approach (MONET)
An observational study of Bone Metastases and Neuroendocrine Neoplasm, run by European Institute of Oncology at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bone Metastases, Neuroendocrine Neoplasm
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jan 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with bone metastases from NENs histologically proved.
Who may be able to join
- 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
Who cannot join
- Small cell lung carcinoma
- MiNEN
- Non neuroendocrine neoplasm
Trial locations and contacts
1 site in 1 country.
Cristina Mazzon, Ph.D. contact
Italy1 site, 1 recruiting
- Recruiting
European Institute of Oncology, IEO, IRCCS
Milan, 20141
Darina Tamayo, PharmSc., +39(0)294372686, darina.tamayo@ieo.it
Cristina Mazzon, Ph.D., +39(0)294372686, cristina.mazzon@ieo.it
About this study
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.
- Conditions
- Bone Metastases, Neuroendocrine Neoplasm
- Keywords
- NET, NEC, Neuroendocrine tumors, Neuroendocrine carcinomas, Bisphosphonates
- Medical subject headings
- Neuroendocrine Tumors, Carcinoma, Neuroendocrine
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival (OS) will be calculated from the date of BM diagnosis to the date of death
Measured: 01/2021 - 12/2021
Influence of skeletal related events (SRE) on survival
Influence of skeletal related events (SRE) on overall survival (OS)
Measured: 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
Measured: 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
Measured: 01/2021 - 12/2021
Secondary outcomes (6)
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
Measured: 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
Measured: 01/2021 - 12/2021
Radiological diagnosis (CT, MRI)
To describe the morphological features of bone metastases in patients with NEN
Measured: 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
Measured: 01/2021 - 12/2021
Impact of antitumor therapy on bone metastases behavior
To describe the global impact of antitumor therapies on bone metastases behavior
Measured: 01/2021 - 12/2021
Impact of supportive care
To describe the global impact of supportive care on overal survival
Measured: 01/2021 - 12/2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start8 Jan 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bone MetastasesStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicola Fazio, M.D., Ph.D., Study chair, European Institute of Oncology, IEO, IRCCSFrancesca Spada, M.D., Ph.D., Principal investigator, European Institute of Oncology, IEO, IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04720391
- Sponsor's protocol ID
- IEO 1436
- Acronym
- MONET
- Status last verified
- Jan 2021
- First submitted
- 20 Jan 2021
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 29295881Grisanti 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Metastases in neurOendocrine NEoplasms: naTural History, Prognostic Impact and Therapeutic Approach (MONET)
- ClinicalTrials.gov ID
- NCT04720391
- Acronym / sponsor ID
- MONET / IEO 1436
- Conditions
- Bone Metastases, Neuroendocrine Neoplasm
- Keywords
- NET, NEC, Neuroendocrine tumors, Neuroendocrine carcinomas, Bisphosphonates
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with bone metastases from NENs histologically proved.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Small cell lung carcinoma
- MiNEN
- Non neuroendocrine neoplasm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: 01/2021 - 12/2021
Overall survival (OS) will be calculated from the date of BM diagnosis to the date of death
Influence of skeletal related events (SRE) on survival
Time frame: 01/2021 - 12/2021
Influence of skeletal related events (SRE) on overall survival (OS)
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
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
Influence of the use of bisphosphonates or RANK-ligands
Time frame: 01/2021 - 12/2021
To evaluate the influence of the use of bisphosphonates or RANK-ligands on overall survival
6 secondary outcomes
Correlation from bone metastases and age, gender, primary site, Ki-67, grade of differentiation
Time frame: 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)
Time frame: 01/2021 - 12/2021
Radiological diagnosis (CT, MRI)
Time frame: 01/2021 - 12/2021
Functional diagnosis (68GaPET/CT-DOTA-peptide, 18FDGPET/CT)
Time frame: 01/2021 - 12/2021
Impact of antitumor therapy on bone metastases behavior
Time frame: 01/2021 - 12/2021
Impact of supportive care
Time frame: 01/2021 - 12/2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Results publication: PubMed 29295881Harding 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.
- Results publication: PubMed 30893350Grisanti 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristina Mazzon, Ph.D. contact
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bone Metastases and Neuroendocrine Neoplasm, run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Darina Tamayo, PharmSc. (+39(0)294372686, darina.tamayo@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 01/2021 - 12/2021). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04720391, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.