NCT04512495已完成不适用
Circulating " Cancer Cells / Macrophage " HYbrid Cells in Patients With Sarcoma?
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Rate of patients with "cancer cell / macrophage" hybrid cells in peripheral blood.
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 sarcoma and treated in the context of routine care.
For each included patient, blood samples will be collected during baseline visit and after the initiation therapy.
At the end of the 2nd 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
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with one of the following subtypes of soft tissue or bone sarcomas: leiomyosarcoma, dedifferentiated liposarcoma, myxoid liposarcoma, synovialosarcoma, osteosarcoma, Ewing's sarcoma.
- •Diagnosis of sarcoma histologically confirmed by the RRePS network (Réseau de Référence en Pathologie des Sarcomes et des Viscères)
- •Age ≥ 18 years old.
- •Localized or metastatic disease or recurrent disease.
- •Patient who has not yet initiated specific treatment for sarcoma.
- •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 procedures.
排除标准
- •Patient with any other histological subtype of sarcoma, including pleomorphic sarcoma.
- •Associated pathology(s) 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).
结局指标
主要结局
Rate of patients with "cancer cell / macrophage" hybrid cells in peripheral blood.
时间窗: 6 months after the end of inclusions
次要结局
- Quantification of circulating hybrid cells in peripheral blood by automatic measurement (Cell Counter Corning) and expressed in number of cells / millilitre of blood.(6 months after the end of inclusions)
研究者
研究点 (2)
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