Research of Double-positive Circulating Cells (Tumor Marker / CD45+) in Several Types of Metastatic Cancers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Rate of patients presenting blood circulating DP cells detected by at least one of the two tested techniques (Flow Cytometry/ CellSearch® or Parsortix® according to the type of tumor)
研究概览
简要总结
A prospective, proof-of-concept pilot study in patients with metastatic cancers (9 types of cancers are studied) treated at the IUCT-O or possibly in other institutions. Eligible patients will be selected and informed of this study during a medical consultation for their cancer by medical oncologists. Then, with the patient's consent and before the start of anti-cancer treatment (whatever the line), a blood sample will be taken to detect DP-circulating cells by 2 different methods of analysis.
Each patient will participate in the study for one day. The methods of analysis will be: flow cytometry for all patients and either Parsotix® or CellSearch® depending on the type of cancer.
450 patients will be enrolled in total.
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
- •Patients with one of the following cancer types: urothelial carcinoma, renal carcinoma, prostate adenocarcinoma, upper aerodigestive tract carcinoma, cervival carcinoma, adenocarcinoma of endometrium, cutaneous melanoma, soft tissue sarcoma, seminomatous and nonseminomatous germ cell tumors
- •Metastatic disease for which the treatment (whatever the line) has not been initiated yet
- •Age ≥ 18 years
- •Patient affiliated to a French Social Security scheme
- •Patient having signed his/her informed consent prior to inclusion in the study and prior to any specific procedure for the study.
排除标准
- •Patient with localized disease.
- •Pregnant or breast-feeding women.
- •Any psychological, family, geographical or sociological condition that prevents compliance with the medical monitoring and/or procedures set out in the study protocol.
- •Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
结局指标
主要结局
Rate of patients presenting blood circulating DP cells detected by at least one of the two tested techniques (Flow Cytometry/ CellSearch® or Parsortix® according to the type of tumor)
时间窗: 1 year after the Last Patient Last Visit
It is defined as the ratio of number of patients for whom DP cells were detected (by at least 1 of the 2 techniques) by the total number of patients.
次要结局
- Rate of patients presenting blood circulating DP cells detected by each method of analysis (Flow Cytometry and CellSearch® or Parsortix® according to the tumor type)(1 year after the Last Patient Last Visit)