Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT04957602
Status:
TERMINATED
Last Update Posted:
2024-07-24
First Post:
2021-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of a Novel Microfluidic Device to Purify Metastatic Lung Cancer Patients CTC (Circulating Tumoral Cells)
Sponsor:
Hospices Civils de Lyon
Organization:
Study Overview
Official Title:
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)
Status:
TERMINATED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
funding ending
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LUTON
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2021-A01838-33 | OTHER | ID-RCB | View |