NCT05988970已完成不适用
Impact of Circadian Rhythm on the Spread of Circulating Tumor Cells in Lung Cancer Patients
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Presence of CTCs detected with the CellSearch technique.
研究概览
简要总结
This is a prospective pilot study designed to demonstrate the impact of circadian rhythm on the spread of Circulating Tumor Cells (CTCs) in patients with Non- Small Cell Lung Cancer - NSCLC.
27 patients will be included in the study and will be followed for 12 months.
For each included patient, blood samples will be collected before the anticancer treatment initiation.
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 histologically confirmed advanced NSCLC (inoperable stage 3 or 4)
- •Patient aged ≥ 18 years
- •Life expectancy > 3 months
- •Patient naïve to treatment for NSCLC
- •Patient hospitalized at least one night for initiation of specific treatment (chemotherapy, radiotherapy, surgery, other...)
- •Patient with no other active cancer. Cancer history accepted if more than 3 years old and considered cured.
- •Patient affiliated to a Social Security scheme in France.
- •Patient having signed informed consent prior to inclusion in the study and prior to any specific study procedure.
排除标准
- •Small-cell cancer or cancer with a majority small-cell contingent
- •Patient previously treated for NSCLC
- •Patient with active pathology such as sepsis or uncontrolled inflammatory syndrome
- •Any pathology contraindicating the sample collection procedures required by the study.
- •Pregnant or breast-feeding women.
- •Any psychological, family, geographical or sociological condition that makes it impossible to comply with the medical follow-up and/or procedures stipulated in the study protocol.
- •Patients deprived of their liberty or under legal protection (guardianship, legal protection).
研究组 & 干预措施
Patients with Non- Small Cell Lung Cancer - NSCLC
Other
干预措施: Blood samples will be collected at two times before the treatment initiation: (Other)
结局指标
主要结局
Presence of CTCs detected with the CellSearch technique.
时间窗: 12 months after the end of inclusions
次要结局
- Progression-free survival (PFS) defined as the time between the date of inclusion and the date of first progression or death.(12 months after the end of inclusions)
- Quantification of CTCs by the CellSearch technique and expressed in number of cells / millilitre of blood.(12 months after the end of inclusions)
- Quantification of CTCs by the ParSortix technique and expressed in number of cells / millilitre of blood.(12 months after the end of inclusions)
- Objective response defined as complete or partial response.(12 months after the end of inclusions)
研究者
研究点 (2)
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