Ultrasensitive BIOsensing Platform for Multiplex CELLular Protein PHEnotyping at Single-cell Level
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Detect specific proteins on CTCs in breast cancer patients
研究概览
简要总结
In the current scenario, a reliable liquid biopsy method for predicting outcomes in solid tumors, especially among breast cancer patients, is lacking. Circulating Tumor Cells (CTCs) serve as crucial indicators of metastasis, and their early detection could significantly enhance patient stratification and facilitate the customization of personalized treatments. However, detecting CTCs in breast cancer patients presents complexities due to their substantial phenotypic heterogeneity and typically low concentration.
Numerous approaches have been developed for CTC detection. Nonetheless, the currently available technologies remain intricate, time-consuming, and costly. The BioCellPhe Project is dedicated to the development of a novel device capable of isolating and characterizing individual CTCs. This innovative device relies on the identification of specific cell membrane proteins with remarkable precision, achieved through the application of novel orthogonal techniques.
On one hand, engineered bacteria are utilized to precisely bind to membrane proteins of interest on CTCs. On the other hand, Surface Enhanced Raman Spectroscopy (SERS) is employed for the detection of individual molecules. Specifically, the BioCellPhe Project focuses on comprehensively studying CTCs in breast cancer patients, encompassing both metastatic and non-metastatic cases.
详细描述
This is an experimental, prospective and monocentric study. This study involves consecutive patients with diagnosis of breast cancer (BC), including early breast cancer and metastatic breast cancer patients, referring to the Breast Unit and to the Oncology Department at Istituti Clinici Scientifici Maugeri, Pavia (Italy).
Patients diagnosed with different histological types of breast cancer will be enrolled in the study: luminal BC, HER2-enriched BC, triple-negative BC.
The study duration is 24 months, starting from December 2022 to December 2024.
The patients will be divided into three groups, as follows:
- Population 1: patients diagnosed with metastatic breast cancer.
- Population 2: patients diagnosed with primary early-breast cancer candidate for surgery.
- Population 3: a control group of sex and age matched healthy volunteers, not affected by any neoplastic disease.
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
- •female patients with diagnosis of metastatic breast cancer, confirmed by clinical practice staging exams.
- •female patients with biopsy-confirmed diagnosis of early-breast cancer candidate for primary surgery after multidisciplinary evaluation.
- •patients not affected by any neoplastic disease.
排除标准
- •Diagnosis of any neoplastic disease
研究组 & 干预措施
MBC
Patients diagnosed with metastatic breast cancer
干预措施: Blood sample (Device)
EBC
Patients diagnosed with primary early-breast cancer candidate for surgery
干预措施: Blood sample (Device)
HC
Control group of sex and age matched healthy volunteers, not affected by any neoplastic disease
干预措施: Blood sample (Device)
结局指标
主要结局
Detect specific proteins on CTCs in breast cancer patients
时间窗: 24 months
Clinical validation of a new technological device able to detect specific target surface proteins on CTCs in breast cancer patients, both non-metastatic and metastatic.
次要结局
未报告次要终点
研究者
Fabio Corsi
Professor
Istituti Clinici Scientifici Maugeri SpA