Clinical trial · Observational
MicroRNAs and Prognosis in Breast Cancer
MicroRNAs Methylation and Expression Profiling for Identification of Breast Cancer Patients at High Risk to Develop Distant Metastases
NCT06555354CI-TRIAL-00079841BREMIRcompletedClinicalTrials.gov clinicaltrialsProvenance
- 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)
Mono-centric, observational retrospective and prospective study, designed for breast cancer patients to identify novel miRNA based biomarker able to predict metastases development in breast cancer patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
| Metastases Breast | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| miRNA profiling of breast cancer tissues | Diagnostic Test | — | UNRESOLVED |
| miRNA targeted analysis on breast cancer tissues | Diagnostic Test | — | UNRESOLVED |
| miRNA targeted analysis on plasma samples | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Retrospective
- description
- Identification in a retrospective cohort of a miRNA panel associated with the development of distant metastases.The retrospective cohort consists of tumor and normal tissue obtained from breast cancer patients, stored at -80°C at the Laboratory of Oncology. Of these samples, 360 met the inclusion criteria.
- interventionNames
- Diagnostic Test: miRNA targeted analysis on breast cancer tissues
- Diagnostic Test: miRNA profiling of breast cancer tissues
- label
- Prospective
- description
- The association between miRNA expression and the clinical course of the disease identified in the retrospective cohort, is being confirmed in an independent prospective cohort. Both normal and tumor tissues of the patients, as well as plasma collected before surgery and at each follow-up time point, is being analyzed. Based on the annual number of surgeries performed at the Breast Surgery Unit, we initially estimated that the prospective cohort would consist of about 500 patients recruited over three years. Since the project was extended for additional two years the actual number of subject recruited was 972. In addition plasma sample for 100 breast benign condition was also collected as controls.
- interventionNames
- Diagnostic Test: miRNA targeted analysis on breast cancer tissues
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Retrospective Cohort Inclusion Criteria: Tissue samples from breast cancer cases diagnosed from 2004 to 2014 for which informed consent for tumour banking and complete clinicopathological and follow up data were available. Exclusion Criteria: Pre-surgery neoadjuvant treatment for breast cancer with chemotherapy, lapatinib, trastuzumab, letrozole, anastrozole, exemestane or tamoxifen. Other cancers diagnosed in the last five years. Prospective Cohort: Inclusion Criteria: Ability to provide written informed consent; Age greater than 18 years; Histological diagnosis of Breast disease; First diagnosis of Breast Cancer; Syncronous distant metastasis absent. Exclusion Criteria: Stage IV breast cancer; Pre-surgery neoadjuvant treatment for breast cancer with chemotherapy, lapatinib, trastuzumab, letrozole, anastrozole, exemestane or tamoxifen; Other cancers diagnosed in the last five years; Alteration of mental status, dementia, or any psychiatric condition that might impair the ability to consciously sign the informed consent.
References
Publications (5)
- BACKGROUNDBarbano R, Pasculli B, Rendina M, Fontana A, Fusilli C, Copetti M, Castellana S, Valori VM, Morritti M, Graziano P, Luigi C, Coco M, Picardo F, Mazza T, Evron E, Murgo R, Maiello E, Esteller M, Fazio VM, Parrella P. Stepwise analysis of MIR9 loci identifies miR-9-5p to be involved in Oestrogen regulated pathways in breast cancer patients. Sci Rep. 2017 Mar 27;7:45283. doi: 10.1038/srep45283. PMID 28345661
- BACKGROUNDPasculli B, Barbano R, Fontana A, Biagini T, Di Viesti MP, Rendina M, Valori VM, Morritti M, Bravaccini S, Ravaioli S, Maiello E, Graziano P, Murgo R, Copetti M, Mazza T, Fazio VM, Esteller M, Parrella P. Hsa-miR-155-5p Up-Regulation in Breast Cancer and Its Relevance for Treatment With Poly[ADP-Ribose] Polymerase 1 (PARP-1) Inhibitors. Front Oncol. 2020 Aug 12;10:1415. doi: 10.3389/fonc.2020.01415. eCollection 2020. PMID 32903519
- BACKGROUNDPasculli B, Barbano R, Rendina M, Fontana A, Copetti M, Mazza T, Valori VM, Morritti M, Maiello E, Graziano P, Murgo R, Fazio VM, Esteller M, Parrella P. Hsa-miR-210-3p expression in breast cancer and its putative association with worse outcome in patients treated with Docetaxel. Sci Rep. 2019 Oct 17;9(1):14913. doi: 10.1038/s41598-019-51581-3. PMID 31624308
- BACKGROUNDFontana A, Barbano R, Dama E, Pasculli B, Rendina M, Morritti MG, Melocchi V, Castelvetere M, Valori VM, Ravaioli S, Bravaccini S, Ciuffreda L, Graziano P, Maiello E, Copetti M, Fazio VM, Esteller M, Bianchi F, Parrella P. Combined analysis of miR-200 family and its significance for breast cancer. Sci Rep. 2021 Feb 3;11(1):2980. doi: 10.1038/s41598-021-82286-1. PMID 33536459
- DERIVEDFontana A, Barbano R, Pasculli B, Mazza T, Palumbo O, Binda E, Trivieri N, Mencarelli G, Laurenzana I, Lamorte D, De Luca L, Caivano A, Biagini T, Rendina M, Lo Mele A, Prencipe G, Bravaccini S, Murgo R, Ciuffreda L, Morritti M, Valori VM, Di Lisa FS, Vici P, Castelvetere M, Carella M, Graziano P, Maiello E, Copetti M, Esteller M, Parrella P. Development of a microRNA-based prognostic model for accurate prediction of distant metastasis in breast cancer patients. Breast Cancer Res. 2025 Sep 29;27(1):170. doi: 10.1186/s13058-025-02124-4.