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
- 1
- 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).
研究组 & 干预措施
Patients with metastatic cancer
-
Blood sample collection for circulating DP cell detection by flow cytometry and Cell Search analysis for the following patients:
-
Cohort 1 : urothelial carcinoma
-
Cohort 2 : renal carcinoma
-
Cohort 3 : prostate adenocarcinoma
-
Cohort 4 : upper aerodigestive tract carcinoma
-
Cohort 5 : cervical carcinoma
-
Cohort 6 : adenocarcinoma of endometrium
-
Blood sample collection for circulating DP cell detection by flow cytometry and Parsotix analysis for the following patients:
-
Cohort 7 : cutaneous melanoma
-
Cohort 8 : soft tissue sarcoma
-
Cohort 9 : seminomatous and nonseminomatous germ cell tumors
干预措施: For each enrolled patient, the sample described below will be collected as specific intervention intended for research purposes: (Other)
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)