NCT04720391

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2021

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

12 months

First QC Date

January 20, 2021

Last Update Submit

January 20, 2021

Conditions

Bone MetastasesNeuroendocrine Neoplasm

Keywords

NETNECNeuroendocrine tumorsNeuroendocrine carcinomasBisphosphonates

Outcome Measures

Primary Outcomes (4)

  • Overall survival

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

    01/2021 - 12/2021

  • Influence of skeletal related events (SRE) on survival

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

    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

    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

    01/2021 - 12/2021

Secondary Outcomes (6)

  • Correlation from bone metastases and age, gender, primary site, Ki-67, grade of differentiation

    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)

    01/2021 - 12/2021

  • Radiological diagnosis (CT, MRI)

    01/2021 - 12/2021

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

    01/2021 - 12/2021

  • Impact of antitumor therapy on bone metastases behavior

    01/2021 - 12/2021

  • +1 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with bone metastases from NENs histologically proved.

You may qualify if:

  • 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

You may not qualify if:

  • Small cell lung carcinoma
  • MiNEN
  • Non neuroendocrine neoplasm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European Institute of Oncology, IEO, IRCCS

Milan, 20141, Italy

RECRUITING

Related Publications (2)

  • 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.

    PMID: 29295881RESULT

  • 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.

    PMID: 30893350RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Neuroendocrine TumorsCarcinoma, Neuroendocrine

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueAdenocarcinomaCarcinomaNeoplasms, Glandular and Epithelial

Study Officials

  • Nicola Fazio, M.D., Ph.D.

    European Institute of Oncology, IEO, IRCCS

    STUDY CHAIR

  • Francesca Spada, M.D., Ph.D.

    European Institute of Oncology, IEO, IRCCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Darina Tamayo, PharmSc.

CONTACT

+39(0)294372686darina.tamayo@ieo.it

Cristina Mazzon, Ph.D.

CONTACT

+39(0)294372686

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2021

First Posted

January 22, 2021

Study Start

January 8, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

January 22, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)