Bone Metastases, Neuroendocrine Neoplasm
Conditions
Keywords
NET, NEC, Neuroendocrine tumors, Neuroendocrine carcinomas, Bisphosphonates
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.
Interventions
None listed
Sponsors
European Institute of Oncology
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 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 | 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 | 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 | 01/2021 - 12/2021 | To evaluate the influence of the use of bisphosphonates or RANK-ligands on overall survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of antitumor therapy on bone metastases behavior | 01/2021 - 12/2021 | To describe the global impact of antitumor therapies on bone metastases behavior |
| 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 | 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 |
| Impact of supportive care | 01/2021 - 12/2021 | To describe the global impact of supportive care on overal survival |
| Correlation from bone metastases and age, gender, primary site, Ki-67, grade of differentiation | 01/2021 - 12/2021 | To evaluate the correlation between bone metastases and patients and tumor's features |
| Radiological diagnosis (CT, MRI) | 01/2021 - 12/2021 | To describe the morphological features of bone metastases in patients with NEN |
| Functional diagnosis (68GaPET/CT-DOTA-peptide, 18FDGPET/CT) | 01/2021 - 12/2021 | To To describe the functional features of bone metastases in patients with NEN |
Countries
Italy
Contacts
Primary ContactDarina Tamayo, PharmSc.
Backup ContactCristina Mazzon, Ph.D.
Outcome results
None listed