Comparison of Different Methods of CAPTure of Circulating Tumour Cells (CTC) in Patients With Metastatic Breast or Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- The rate of patients with at least one additional CTC detected by the SmartCatch® method compared with the standard approach (CellSearch®).
研究概览
简要总结
This trial is a pilot, prospective, single-center study conducted in a population of patients with metastatic breast cancer (whatever the immunohistochemical subtype) or metastatic prostate cancer. The aim of this exploratory study is to compare the sensitivity of three different techniques (CellSearch®, Parsortix® and SmartCatch®) in detecting circulating tumor cells (CTCs). After the patient's agreement, and before starting anti-tumor treatment, a blood sample will be taken using the 3 different CTC detection techniques.
Each patient will participate in the study for one day.
A total of 54 evaluable patients (36 patients with metastatic breast cancer and 18 patients with metastatic prostate cancer) will be included in this interventional study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with breast cancer (whatever the immunohistochemical subtype: triple-negative, RH+/HER2-negative or HER2-positive) or prostate cancer, multi-metastatic, eligible for a new line of treatment.
- •Patient not yet initiated on a new specific treatment for breast or prostate cancer at inclusion.
- •Age ≥ 18 years and WHO ≤ 2
- •Patient affiliated to Social Security scheme in France.
- •Patient having signed informed consent prior to inclusion in the study and prior to any study-specific procedures.
排除标准
- •Associated pathology(ies) likely to prevent the study procedure from running smoothly
- •Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures stipulated in the study protocol.
- •Patient deprived of liberty or under legal protection (guardianship, legal protection)
- •Patient who has had another solid tumor (excluding carcinoma in situ of the breast or cervix) within 5 years.
研究组 & 干预措施
Patients with metastatic breast cancer or prostate cancer
干预措施: Taking blood samples before starting treatment (Other)
结局指标
主要结局
The rate of patients with at least one additional CTC detected by the SmartCatch® method compared with the standard approach (CellSearch®).
时间窗: 15 months after the study start
It is defined by the ratio of the number of patients with at least one additional CTC detected by the SmartCatch® method compared with the standard approach (CellSearch®) to the total number of patients.
次要结局
- The rate of patients with CTCs (CK+/CD45-) detected by each technique (CellSearch®, Parsortix® and SmartCatch®).(15 months after the study start)
- The number of total CTCs (EpCAM+/CK+/CD45- and EpCAM-/CK+/CD45-) detected by the different techniques (CellSearch®, Parsortix® and SmartCatch®).(15 months after the study start)