NCT03895216: PreMetOn

Identification and Characterization of Predictive Factors of Onset of Bone Metastases in Cancer Patients

Completed Last updated 22 March 2022

What this trial tests

trial in Bone Metastases in 34 participants. Completed in 31 December 2021.

Timeline

3 December 2018

Primary endpoint
31 May 2021

31 December 2021

Quick facts

Lead sponsor	Istituto Ortopedico Rizzoli
Status	Completed
Study type	OBSERVATIONAL
Enrollment	34
Start date	3 December 2018
Primary completion	31 May 2021
Estimated completion	31 December 2021
Sites	1 location across Italy

Conditions studied

• Bone Metastases — all drugs for Bone Metastases →

Sponsor

Istituto Ortopedico Rizzoli — full company profile →

Who can join

18 and older, any sex, with Bone Metastases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The aim of the present study is to identify deregulated miRNAs in oncological patients with bone metastases present within the circulating exosomes and responsible for the biological mechanisms involved in the process of bone metastasis, in order to obtain a panel of biomarkers predictive of this risk.

Through appropriate molecular screening methods a specific panel of significantly deregulated miRNAs will be identified; subsequently bioinformatics analyzes through the use of dedicated databases will be carried out, based on literature data and predicted protein targets in order to identify their potential role in tumor progression, and especially in the onset of bone metastases. Attention, therefore, may be focused on the individual miRNAs identified through individual analysis analyzes of gene expression. These biomarkers could also serve as therapeutic targets, allowing to improve the effectiveness of current therapies and to undertake timely and appropriate therapeutic choices, developed on the basis of the patient's molecular characteristics

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cancer-Derived Exosomes: Their Role in Cancer Biology and Biomarker Development.
   Kok VC, Yu CC. · · 2020 · cited 318× · PMID 33116515 · DOI 10.2147/ijn.s272378
2. Small extracellular vesicles isolation and separation: Current techniques, pending questions and clinical applications.
   Jia Y, Yu L, Ma T, Xu W, et al · · 2022 · cited 229× · PMID 36185597 · DOI 10.7150/thno.74305
3. Potential Use of Exosomes as Diagnostic Biomarkers and in Targeted Drug Delivery: Progress in Clinical and Preclinical Applications.
   Huda MN, Nafiujjaman M, Deaguero IG, Okonkwo J, et al · · 2021 · cited 160× · PMID 33988964 · DOI 10.1021/acsbiomaterials.1c00217
4. Synergies in exosomes and autophagy pathways for cellular homeostasis and metastasis of tumor cells.
   Salimi L, Akbari A, Jabbari N, Mojarad B, et al · · 2020 · cited 102× · PMID 32426106 · DOI 10.1186/s13578-020-00426-y
5. Clinical applications for exosomes: Are we there yet?
   Perocheau D, Touramanidou L, Gurung S, Gissen P, et al · · 2021 · cited 101× · PMID 33751579 · DOI 10.1111/bph.15432
6. The Emerging Roles of Exosomes as EMT Regulators in Cancer.
   Kim H, Lee S, Shin E, Seong KM, et al · · 2020 · cited 87× · PMID 32252322 · DOI 10.3390/cells9040861
7. Immune Microenvironment in Osteosarcoma: Components, Therapeutic Strategies and Clinical Applications.
   Zhu T, Han J, Yang L, Cai Z, et al · · 2022 · cited 80× · PMID 35720360 · DOI 10.3389/fimmu.2022.907550
8. Cancer-Derived Extracellular Vesicle-Associated MicroRNAs in Intercellular Communication: One Cell's Trash Is Another Cell's Treasure.
   Mills J, Capece M, Cocucci E, Tessari A, et al · · 2019 · cited 51× · PMID 31817101 · DOI 10.3390/ijms20246109