Lung Cancer
Conditions
Keywords
Circadian rhythm, Circulating tumor cells, CTC, CellSearch, ParSortix
Brief summary
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.
Interventions
OTHERBlood samples will be collected at two times before the treatment initiation:
* 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).
Sponsors
Institut Claudius Regaud
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient with histologically confirmed advanced NSCLC (inoperable stage 3 or 4) 2. Patient aged ≥ 18 years 3. Life expectancy \> 3 months 4. Patient naïve to treatment for NSCLC 5. Patient hospitalized at least one night for initiation of specific treatment (chemotherapy, radiotherapy, surgery, other...) 6. Patient with no other active cancer. Cancer history accepted if more than 3 years old and considered cured. 7. Patient affiliated to a Social Security scheme in France. 8. Patient having signed informed consent prior to inclusion in the study and prior to any specific study procedure.
Exclusion criteria
1. Small-cell cancer or cancer with a majority small-cell contingent 2. Patient previously treated for NSCLC 3. Outpatient 4. Patient with active pathology such as sepsis or uncontrolled inflammatory syndrome 5. Any pathology contraindicating the sample collection procedures required by the study. 6. Pregnant or breast-feeding women. 7. 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. 8. Patients deprived of their liberty or under legal protection (guardianship, legal protection).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence of CTCs detected with the CellSearch technique. | 12 months after the end of inclusions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 12 months after the end of inclusions | Response will be assessed according to the clinician's judgment. |
| 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 | — |
Countries
France
Outcome results
None listed