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

Institut Claudius Regaud

Status: Completed

Conditions: Lung Cancer

Treatments: Other: Blood samples will be collected at two times before the treatment initiation:

Study type: Interventional

Funder types: Other

Identifiers

NCT05988970

23 POUM 02

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Patients with Non- Small Cell Lung Cancer - NSCLC

Other group

Treatment:

Other: Blood samples will be collected at two times before the treatment initiation: