Clinical trial NCT05988970: Impact of Circadian Rhythm on the Spread of Circulating Tumor Cells in Lung Cancer Patients
Official title: Impact of Circadian Rhythm on the Spread of Circulating Tumor Cells in Lung Cancer Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: Circadian rhythm
Circulating tumor cells
CTC
CellSearch
ParSortix
Lead sponsor: Institut Claudius Regaud
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Presence of CTCs detected with the CellSearch technique.
timeFrame: 12 months after the end of inclusions
Secondary outcomes:
measure: Quantification of CTCs by the CellSearch technique and expressed in number of cells / millilitre of blood.
timeFrame: 12 months after the end of inclusions
measure: Quantification of CTCs by the ParSortix technique and expressed in number of cells / millilitre of blood.
timeFrame: 12 months after the end of inclusions
measure: Objective response defined as complete or partial response.
timeFrame: 12 months after the end of inclusions
measure: Progression-free survival (PFS) defined as the time between the date of inclusion and the date of first progression or death.
timeFrame: 12 months after the end of inclusions
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Hôpital Larrey
city: Toulouse
country: France
facility: Institut Universitaire du Cancer de Toulouse - Oncopole
Study officials:
References: