MicroRNAs Methylation and Expression Profiling for Identification of Breast Cancer Patients at High Risk to Develop Distant Metastases
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer Female
- Sponsor
- Casa Sollievo della Sofferenza IRCCS
- Enrollment
- 1432
- Locations
- 1
- Primary Endpoint
- Risk of metastases development
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Paola Parrella
Medical Doctor
Casa Sollievo della Sofferenza IRCCS
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Risk of metastases development
Time Frame: evaluation 5 and 10 years after diagnosis
Identification of miRNAs associated with the risk to develop distant metastases.
Secondary Outcomes
- Overall Survival(evaluation 5 and 10 years after diagnosis)