NCT04818125已完成不适用
Circulating Cancer Cells/Macrophage HYbrid Cells in Patients With Breast Cancer.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Rate of patients with cancer cell / macrophage hybrid cells in peripheral blood defined as the ratio of the number of patients with hybrid cells to the total number of patients.
研究概览
简要总结
Pilot, prospective, monocentric study aimed at evaluating the rate of patients with circulating cancer cell/macrophage hybrid cells in the peripheral blood.
The study will be conducted on a population of patients with breast cancer (regardless of stage of the disease and the immunohistochemical subtype).
For each included patient, blood samples will be taken and tumor specimens will be collected for the study.
At the end of the blood collection, the patient will have completed his participation in the 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient with breast cancer of any stage (stage I, II, III or IV) and any immunohistochemical subtype (triple-negative, HR+/HER2-negative or HER2-positive).
- •Patient not yet initiated on specific treatment for the stage of breast cancer at inclusion.
- •Available tumor sample (archived tumor block) : initial tumor or metastasis depending on the stage of the disease and availability.
- •Age ≥ 18 years old.
- •Patient affiliated to a Social Health Insurance in France.
- •Patient having signed informed consent prior to inclusion in the study and prior to any specific study procedure.
排除标准
- •Associated pathology(ies) that may prevent the proper conduct of the procedure under consideration.
- •Pregnant or breastfeeding woman.
- •Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of 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).
- •Patient who has presented another solid tumor (except breast or cervix carcinoma in situ) within 5 years.
结局指标
主要结局
Rate of patients with cancer cell / macrophage hybrid cells in peripheral blood defined as the ratio of the number of patients with hybrid cells to the total number of patients.
时间窗: 20 months after the study start
次要结局
- Progression-free survival (PFS) defined as the time from the date of inclusion to the date of progression or death from any cause.(20 months after the study start)
- Quantification of circulating hybrid cells in peripheral blood by automatic measurement (Cell Counter Corning) and expressed in number of cells / millilitre of blood.(20 months after the study start)
研究者
研究点 (1)
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