MicroRNAs and Prognosis in Breast Cancer

Casa Sollievo della Sofferenza IRCCS1,432 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

1,432

Conditions

Breast Cancer Female Metastases Breast

Interventions

miRNA targeted analysis on breast cancer tissuesDIAGNOSTIC_TEST

Total RNA is extracted from tissue sample and selected miRNA quantified by PCR based relative quantification method (QPCR) with a standard curve.

miRNA targeted analysis on plasma samplesDIAGNOSTIC_TEST

miRNAs extracted from plasma samples are analysed by QPCR and/or ddPCR .

miRNA profiling of breast cancer tissuesDIAGNOSTIC_TEST

Selected samples from the retrospective cohort are profiled for miRNA expression by using GeneChip® miRNA 4.0 Array.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Casa sollievo della Sofferenza IRCCS

San Giovanni Rotondo, FG, Italy

Outcomes

Primary Outcomes

Risk of metastases development

Identification of miRNAs associated with the risk to develop distant metastases.

Time frame: evaluation 5 and 10 years after diagnosis

Secondary Outcomes

Overall Survival

Identification of miRNAs associated with the risk of cancer specific death

Time frame: evaluation 5 and 10 years after diagnosis

Data from ClinicalTrials.gov

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