NCT05427461进行中（未招募）不适用
Circulating " Cancer Cells / Macrophage " HYbrid Cells in Patients With Sarcoma, Part 2
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- The longitudinal evolution of 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 and the evolution of this rate over time.
The study will be conducted on a population of patients with leiomyosarcoma and treated in the context of routine care. 20 patients will be included:
- 10 patients with localized disease.
- 10 patients with metastatic disease.
For each included patient, blood samples will be collected during baseline visit and up to 24 months after inclusion.
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 leiomyosarcoma.
- •Diagnosis of sarcoma histologically confirmed by the RRePS network (Réseau de Référence en Pathologie des Sarcomes et des Viscères)
- •Localized or metastatic disease
- •Newly diagnosed patient who has not yet initiated specific treatment for sarcoma
- •Age ≥ 18 years
- •Patient affiliated to a Social Security system in France.
- •Patient having signed informed consent prior to inclusion in the study and prior to any specific study procedures
排除标准
- •Diagnosis of any other histological subtype of soft tissue sarcoma
- •Associated pathology(ies) that may interfere with the study procedure
- •Pregnant or breastfeeding woman
- •Any psychological, family, geographical or sociological condition that does not allow for compliance with the medical follow-up and/or procedures provided for 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
The longitudinal evolution of rate of patients with "cancer cell / macrophage" hybrid cells in peripheral blood.
时间窗: 24 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.(24 months after the end of inclusions.)
研究者
研究点 (2)
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