Breast Cancer Female, Metastases Breast
Conditions
Keywords
microRNA, prognosis, risk prediction
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTmiRNA targeted analysis on breast cancer tissues
Total RNA is extracted from tissue sample and selected miRNA quantified by PCR based relative quantification method (QPCR) with a standard curve.
DIAGNOSTIC_TESTmiRNA targeted analysis on plasma samples
miRNAs extracted from plasma samples are analysed by QPCR and/or ddPCR .
DIAGNOSTIC_TESTmiRNA profiling of breast cancer tissues
Selected samples from the retrospective cohort are profiled for miRNA expression by using GeneChip® miRNA 4.0 Array.
Sponsors
Casa Sollievo della Sofferenza IRCCS
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Risk of metastases development | evaluation 5 and 10 years after diagnosis | Identification of miRNAs associated with the risk to develop distant metastases. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | evaluation 5 and 10 years after diagnosis | Identification of miRNAs associated with the risk of cancer specific death |
Countries
Italy
Outcome results
None listed