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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04720391
Other study ID # IEO 1436
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 8, 2021
Est. completion date December 31, 2021

Study information

Verified date January 2021
Source European Institute of Oncology
Contact Darina Tamayo, PharmSc.
Phone +39(0)294372686
Email darina.tamayo@ieo.it
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. - 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Locations

Country Name City State
Italy European Institute of Oncology, IEO, IRCCS Milan

Sponsors (1)

Lead Sponsor Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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 — View 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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Overall survival Overall survival (OS) will be calculated from the date of BM diagnosis to the date of death 01/2021 - 12/2021
Primary Influence of skeletal related events (SRE) on survival Influence of skeletal related events (SRE) on overall survival (OS) 01/2021 - 12/2021
Primary 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 01/2021 - 12/2021
Primary Influence of the use of bisphosphonates or RANK-ligands To evaluate the influence of the use of bisphosphonates or RANK-ligands on overall survival 01/2021 - 12/2021
Secondary 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 01/2021 - 12/2021
Secondary 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 01/2021 - 12/2021
Secondary Radiological diagnosis (CT, MRI) To describe the morphological features of bone metastases in patients with NEN 01/2021 - 12/2021
Secondary Functional diagnosis (68GaPET/CT-DOTA-peptide, 18FDGPET/CT) To To describe the functional features of bone metastases in patients with NEN 01/2021 - 12/2021
Secondary Impact of antitumor therapy on bone metastases behavior To describe the global impact of antitumor therapies on bone metastases behavior 01/2021 - 12/2021
Secondary Impact of supportive care To describe the global impact of supportive care on overal survival 01/2021 - 12/2021
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