MicroRNAs and Prognosis in Breast Cancer
- Conditions
- Breast Cancer FemaleMetastases Breast
- Registration Number
- NCT06555354
- Lead Sponsor
- Casa Sollievo della Sofferenza IRCCS
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1432
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.
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Risk of metastases development evaluation 5 and 10 years after diagnosis Identification of miRNAs associated with the risk to develop distant metastases.
- Secondary Outcome Measures
Name Time Method Overall Survival evaluation 5 and 10 years after diagnosis Identification of miRNAs associated with the risk of cancer specific death
Trial Locations
- Locations (1)
Casa sollievo della Sofferenza IRCCS
🇮🇹San Giovanni Rotondo, FG, Italy
Casa sollievo della Sofferenza IRCCS🇮🇹San Giovanni Rotondo, FG, Italy