Characterization of Extracellular Vesicles in Breast Cancer Patients' Plasma by Single Molecule Detection Array (SiMoA) Digital ELISA
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- EVs levels in early BC
研究概览
简要总结
Extracellular vesicles (EVs) are lipid bilayer-delimited particles, naturally released from cells and mediators of intercellular cross-talk. In breast cancer (BC), EVs seem to be involved in the tumor microenvironment's shaping, in cancer cells invasion and in the set-up of metastasis.
Clinical studies have provided initial evidence that these vesicles may have a prognostic and predictive value in breast cancer. Considering their ubiquitous presence in body fluids and their minimally invasive assessment through blood sampling, EVs could have a potential as liquid biopsy-derived biomarkers. Their quantification though is a complex task requiring complicated and time-consuming pre-analytical procedures of EVs isolation.
This protocol want to develop a new method for the detection of tumor-derived-EVs associated proteins, based on the use of Single Molecule Array (SiMoA), a digital ELISA technology able to detect and quantify extremely low concentrations of target proteins or particles.
The aim of this study is to evaluate how this new technology can allow the quantification of EVs plasma levels in patients affected by BC, providing useful diagnostic and prognostic information.
详细描述
This is a prospective, observational, monocentric and no profit study. The study involves the analysis of plasma from patients with breast cancer in order to quantify and characterize tumor-derived EVs at specific disease stages.
The enrollment of consecutive patients affected by BC referring to an EUSOMA-accredited Breast Unit is planned.
The patients will be divided into three pre-planned groups, as follows:
Population 1: patients diagnosed with early breast cancer patients (stage I-III) with indication to curative surgery.
Population 2: a control group made of sex- and age-matched healthy volunteers, not affected by cancer or chronic diseases.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Signing of a specific informed consent for participation to the study
- •Female sex
- •Population 1:
- •Diagnosis of early breast cancer;
- •Indication for surgery after multidisciplinary discussion.
- •Population 2:
- •- Patients having a negative mammography or breast ultrasound within 12 months from the study enrollment.
- •Population 3:
- •Diagnosis of metastatic breast cancer confirmed by cytological/histological examination or by imaging;
- •Indication to chemotherapy.
排除标准
- •Population 1:
- •Presence of distant metastases
- •Synchronous presence of a different tumor
- •Indication to neoadjuvant chemotherapy
- •Population 2:
- •Diagnosis of breast cancer
- •Synchronous presence of a different tumor or chronic disease
- •Population 3:
- •- Patients who are unfit for systemic chemotherapy treatment
结局指标
主要结局
EVs levels in early BC
时间窗: 36 months
Determination of plasma EVs levels in patients with EBC by SIMOA digital ELISA and evaluation of the difference of their concentration compared to healthy controls
EVs levels in metastatic BC
时间窗: 36 months
Determination of plasma EVs levels in patients with first diagnosis of metastatic BC by SIMOA digital ELISA and evaluation of the difference of their concentration compared to healthy controls
次要结局
- EVs levels after surgery(36 months)
- EVs levels after chemotherapy treatment(36 months)
研究者
Fabio Corsi
Prof
Istituti Clinici Scientifici Maugeri SpA