Clinical trial · Observational
Identification and Characterization of Predictive Factors of Onset of Bone Metastases in Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Metastases | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Changes in miRNAs content of circulating tumor exosomes
- timeFrame
- Within 24 hours before surgery, within 48 hours of metastasectomy or bone biopsy, and follow-up checks at 1, 3, 6 months and 1 year
- description
- Identification of miRNA isolated from circulating tumor exosomes and their changes will be done through expression profiling studies using Next Generation Sequencing (NGS) during follow-up time points. Molecular characterization will be performed on miRNA samples isolated from circulating tumor exosomes separated from the plasma in order to identify new markers related to tumor progression (bone metastases).
- measure
- Change in protein content of circulating tumor exosomes
- timeFrame
- Within 24 hours before surgery, within 48 hours of metastasectomy or bone biopsy, and follow-up checks at 1, 3, 6 months and 1 year
- description
- Qualitative and quantitative proteomic analysis of the content of circulating tumor exosomes will be performed by using Triple TOF mass spectrophotometer and variation during follow-up time points wil be measured.
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of oncological pathology with evidence of disease progression and presence of bone metastases; * Patients who have to undergo biopsy of bone metastases or clinical metastasectomy. The analysis of the circulated biomarkers is done in all patients who are subjected to biopsy or metastasis resection to be sure of the diagnosis of bone metastasis, and to have the opportunity to follow patients in the follow-up provided by this type of surgical treatment. * Life expectancy over 6 months; * Patients able to provide written informed consent to the study. Exclusion Criteria: * Severe cognitive deficits or psychiatric disorders; * Patients who do not wish or cannot comply with the study protocol; * Women of childbearing age who are pregnant or breast-feeding. The protocol excludes pregnant patients because, in the case of metastasectomy, the anesthesia associated with this procedure is completely discouraged in pregnant women and, in addition, any factor is to be avoided (such as a different hormonal arrangement linked to pregnancy ) that can jeopardize or introduce a bias in the results.
References
Publications (5)
- RESULTRaimondi L, De Luca A, Costa V, Amodio N, Carina V, Bellavia D, Tassone P, Pagani S, Fini M, Alessandro R, Giavaresi G. Circulating biomarkers in osteosarcoma: new translational tools for diagnosis and treatment. Oncotarget. 2017 Aug 3;8(59):100831-100851. doi: 10.18632/oncotarget.19852. eCollection 2017 Nov 21. PMID 29246026
- RESULTGraveel CR, Calderone HM, Westerhuis JJ, Winn ME, Sempere LF. Critical analysis of the potential for microRNA biomarkers in breast cancer management. Breast Cancer (Dove Med Press). 2015 Feb 23;7:59-79. doi: 10.2147/BCTT.S43799. eCollection 2015. PMID 25759599
- RESULTMacias M, Alegre E, Diaz-Lagares A, Patino A, Perez-Gracia JL, Sanmamed M, Lopez-Lopez R, Varo N, Gonzalez A. Liquid Biopsy: From Basic Research to Clinical Practice. Adv Clin Chem. 2018;83:73-119. doi: 10.1016/bs.acc.2017.10.003. Epub 2017 Nov 23. PMID 29304904
- RESULTKai K, Dittmar RL, Sen S. Secretory microRNAs as biomarkers of cancer. Semin Cell Dev Biol. 2018 Jun;78:22-36. doi: 10.1016/j.semcdb.2017.12.011. Epub 2017 Dec 19. PMID 29258963
- RESULTLi A, Zhang T, Zheng M, Liu Y, Chen Z. Exosomal proteins as potential markers of tumor diagnosis. J Hematol Oncol. 2017 Dec 27;10(1):175. doi: 10.1186/s13045-017-0542-8. PMID 29282096