Impact of Circadian Rhythm on the Spread of Circulating Tumor Cells in Lung Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Circadian Rhythm on the Spread of Circulating Tumor Cells in Lung Cancer Patients

Conditions
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Lung Cancer

Intervention / Treatment
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* Other: Blood samples will be collected at two times before the treatment initiation:


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Small-cell cancer or cancer with a majority small-cell contingent Patient previously treated for NSCLC Outpatient 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with Non- Small Cell Lung Cancer - NSCLC<br> | Other: Blood samples will be collected at two times before the treatment initiation:<br>* at 4:00 a.m. at 10:00 a.m. Patients will then be followed for data collection for a period of 12 months after inclusion or until disease progression (if applicable).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of CTCs detected with the CellSearch technique. |  | 12 months after the end of inclusions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Response will be assessed according to the clinician's judgment. | 12 months after the end of inclusions | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Circadian rhythm, Circulating tumor cells, CTC, CellSearch, ParSortix