MicroRNAs Methylation and Expression Profiling for Identification of Breast Cancer Patients at High Risk to Develop Distant Metastases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,432
- 试验地点
- 1
- 主要终点
- Risk of metastases development
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Risk of metastases development
时间窗: evaluation 5 and 10 years after diagnosis
Identification of miRNAs associated with the risk to develop distant metastases.
次要结局
- Overall Survival(evaluation 5 and 10 years after diagnosis)
研究者
Paola Parrella
Medical Doctor
Casa Sollievo della Sofferenza IRCCS