Evaluation of a Novel Microfluidic Device to Purify Metastatic Lung Cancer Patients CTC (Circulating Tumoral Cells) (LUTON)

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)

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.

Study Overview

• Status: Terminated
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Other: Blood collection

• Study Type: Observational
• Enrollment (Actual): 6

Contacts and Locations

Study Locations

• France
  • Pierre-Bénite, France, 69495
    • Centre Hospitalier Lyon Sud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Metastatic non-small cell lung cancer patients

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patient weight below 50kg at inclusion
• Suspected Pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Metastatic non-small cell lung cancer patients; Metastatic non-small cell lung cancer patients who have not initiated their treatment yet (osermertinib or chemotherapy (associated or not with immunotherapy)	Other: Blood collection; Blood collection (4*10ml) before treatment initiation and after the first evaluation (usually 3-4 months after treatment initiation).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2 days CTCs viability evaluation after purification by our innovative LUTON 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).	2 days after injection in the microfluidic device.

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Sébastien COURAUD, PhD, Service de Pneumologie Aiguë Spécialisée et Cancérologie thoracique

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2022
• Primary Completion (Actual): September 29, 2022
• Study Completion (Actual): September 29, 2022

Study Registration Dates

• First Submitted: July 6, 2021
• First Submitted That Met QC Criteria: July 9, 2021
• First Posted (Actual): July 12, 2021

Study Record Updates

• Last Update Posted (Actual): July 24, 2024
• Last Update Submitted That Met QC Criteria: July 23, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: non-small cell lung cancer; metastatic
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 69HCL21_0928; 2021-A01838-33 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No