Non Small Cell Lung CancerLUTONNCT04957602
Evaluation of a Novel Microfluidic Device to Purify Metastatic Lung Cancer Patients CTC (Circulating Tumoral Cells)
An observational study of Non Small Cell Lung Cancer, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- Blood collection
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 20 May 2022to 29 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Metastatic non-small cell lung cancer patients
Who may be able to join
- 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
Who cannot join
- Patient weight below 50kg at inclusion
- Suspected Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read more
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.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Blood collection
- Keywords
- metastatic, non-small cell lung cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionOther
Blood collection (4*10ml) before treatment initiation and after the first evaluation (usually 3-4 months after treatment initiation).
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 days after injection in the microfluidic device.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start20 May 2022
- Primary completion29 Sep 2022
- Study completion29 Sep 2022
Why it stopped: funding ending
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sébastien COURAUD, PhD, Principal investigator, Service de Pneumologie Aiguë Spécialisée et Cancérologie thoracique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04957602
- Sponsor's protocol ID
- 69HCL21_0928
- Other IDs
- 2021-A01838-33
- Acronym
- LUTON
- Status last verified
- Jul 2024
- First submitted
- 6 Jul 2021
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04957602
- Acronym / sponsor ID
- LUTON / 69HCL21_0928
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- metastatic, non-small cell lung cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: funding ending
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 20 May 2022 (actual)
- Primary completion
- 29 Sep 2022 (actual)
- Study completion
- 29 Sep 2022 (actual)
- First posted
- 12 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metastatic non-small cell lung cancer patients | – | Other: Blood collectionMetastatic non-small cell lung cancer patients who have not initiated their treatment yet (osermertinib or chemotherapy (associated or not with immunotherapy) |
Who may qualify
- Ages
- 18 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Metastatic non-small cell lung cancer patients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patient weight below 50kg at inclusion
- Suspected Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood collectionBlood collection (4*10ml) before treatment initiation and after the first evaluation (usually 3-4 months after treatment initiation). | Other | Metastatic non-small cell lung cancer patients |
Primary outcome
2 days CTCs viability evaluation after purification by our innovative LUTON microfluidic device
Time frame: 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).
Results and safety
The study was stopped early (reason given: funding ending). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sébastien COURAUD, PhD principal investigator
Service de Pneumologie Aiguë Spécialisée et Cancérologie thoracique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: funding ending). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2 days CTCs viability evaluation after purification by our innovative LUTON microfluidic device (time frame: 2 days after injection in the microfluidic device.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.