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临床试验/NCT04957602
NCT04957602终止不适用

Evaluation of a Novel Microfluidic Device to Purify Metastatic Lung Cancer Patients CTC (Circulating Tumoral Cells and Enable Their Culture (in Vitro and in Ovo)

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2022年5月20日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
6
试验地点
1
主要终点
2 days CTCs viability evaluation after purification by our innovative LUTON microfluidic device

研究概览

简要总结

Currents strategies for cancer diagnosis consist of the extraction of a solid tissue from the affected area. This sample enables the study of specific biomarkers and the genetic nature of the tumor.

However, the tissue extraction is risky and painful for the patient and in some cases is unavailable in inaccessible tumors.

In addition, cancer is a dynamic disease and during the course of disease, cancers generally become more heterogeneous. As a result of this heterogeneity, the bulk tumour might include a diverse collection of cells harbouring distinct molecular signatures with differential levels of sensitivity to treatment. This heterogeneity might result in a non-uniform distribution of genetically distinct tumour-cell subpopulations across and within disease sites (spatial heterogeneity) or temporal variations in the molecular makeup of cancer cells (temporal heterogeneity).

To overcome these drawbacks, new alternatives are rising up, such as liquid biopsy.

A liquid biopsy is the analysis of biomarkers in a non-solid biological tissue, mainly blood, which has remarkable advantages over the traditional method; it has no risk, it is non-invasive and painless, it does not require surgery and reduces cost and diagnosis time.

Of the various circulating biomarkers, circulating tumor cells (CTCs) have particularly opened new windows. Circulating tumor cells (CTCs) are released into the bloodstream from primary cancer, metastasis, and even from a disseminated tumor cell reservoir.

CTCs may ideally replace tissue biopsies in the prediction and monitoring of therapeutic responses and tumor recurrence. CTCs can be used to guide therapeutic cancer management and serve as drug targets.

There are a wide range of instruments and methods for capturing, enriching, and enumerating CTCs. However, none of them is considered optimal.

To improve the purity of CTCs, the study consortium has developed a cutting-edge microfluidic device (LUTON) to reduce leukocytes contamination while preserving CTCs viability.

The added-value of the study innovation has been validated on clinical cell lines. The aim of this study is now to determine the performance of the device using patients' blood samples.

For this purpose, CTCs from non-small cell lung metastatic cancer patients will be isolated using ClearCellFX1 before injection into the LUTON workflow.

Collected cells will then be either growth in vitro or in ovo and the added value of this extra step of purification determined.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 130 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult Patient (>18 years)
  • Stage IV non-small cell lung cancer (depending on classification)
  • First line treatment approved by Multidisciplinary Team Meeting (MDTM) and referent physician
  • Able to provide non-objection to participation

排除标准

  • Patient weight below 50kg at inclusion
  • Suspected Pregnancy

结局指标

主要结局

2 days CTCs viability evaluation after purification by our innovative LUTON microfluidic device

时间窗: 2 days after injection in the microfluidic device.

Circulating Tumoral Cells (CTCs) from blood samples will be retrieved and enriched by ClearCellFX1 before being injected in the LUTON workflow. Purified CTCs will then be collected after their passage into the microfluidic device to be cultivate in 3D. After 2 Days, a "Live and Dead" test will be realized to quantified the amount of living cells (30 samples from diagnosis).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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