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

Sponsor

Institut Claudius Regaud (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05988970

Collaborator

(none)

Enrollment

Locations

Arm

Anticipated Duration (Months)

13.5

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Other: Blood samples will be collected at two times before the treatment initiation:	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

27 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Other: Patients with Non- Small Cell Lung Cancer - NSCLC	Other: Blood 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).

Arm

Intervention/Treatment

Other: Patients with Non- Small Cell Lung Cancer - NSCLC

Other: Blood 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).

Outcome Measures

Primary Outcome Measures

Presence of CTCs detected with the CellSearch technique. [12 months after the end of inclusions]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).