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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.
The potential role of miRNAs will be studied as a predictor of metastases development. miRNAs expression and miRNAs promoter methylation will be evaluated in surgically removed specimens obtained from breast cancer patients at diagnosis. Relevant miRNAs will be first identified by analysing a retrospective breast cancer cohort including at least and subsequently validated on a prospective cohort.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective | 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. |
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| Prospective | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| miRNA targeted analysis on breast cancer tissues | Diagnostic Test | Total RNA is extracted from tissue sample and selected miRNA quantified by PCR based relative quantification method (QPCR) with a standard curve. |
| Measure | Description | Time Frame |
|---|---|---|
| Risk of metastases development | Identification of miRNAs associated with the risk to develop distant metastases. | evaluation 5 and 10 years after diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Identification of miRNAs associated with the risk of cancer specific death | evaluation 5 and 10 years after diagnosis |
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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.
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Retrospective Cohort: 260 patients diagnosed with breast cancer of any histological type that underwent surgery for breast cancer from 2004 to 2014. For all this subjects fresh frozen specimen collected at the time of surgery are available for DNA and/or RNA extraction.
Prospective cohort: 1072 individuals were enrolled in this study from December 2014 to December 2019: 972 patients were affected by breast cancer, 100 patients showed benign breast lesions. For all this subjects fresh frozen specimen and/or FFPE sample at diagnosis, together with a plasma sample collected at the time of surgery are available for DNA and/or RNA extraction. For invasive breast cancer at least two plasma samples were colleted at surgery and after surgery. A third plasma sample is being collected at the eventual progression.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Casa sollievo della Sofferenza IRCCS | San Giovanni Rotondo | FG | 71013 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28345661 | Background | Barbano 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. | |
| 32903519 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 26, 2018 | Aug 9, 2024 | Prot_SAP_000.pdf |
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RNA and DNA obtained from fresh frozen and/or FFPE tissues Plasma Sample for miRNA analyses
| miRNA targeted analysis on plasma samples | Diagnostic Test | miRNAs extracted from plasma samples are analysed by QPCR and/or ddPCR . |
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| miRNA profiling of breast cancer tissues | Diagnostic Test | Selected samples from the retrospective cohort are profiled for miRNA expression by using GeneChip® miRNA 4.0 Array. |
|
| Background |
| Pasculli 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. |
| 31624308 | Background | Pasculli 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. |
| 33536459 | Background | Fontana 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. |
| 41024243 | Derived | Fontana 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. |