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

NCT ID: NCT05988970

Last Updated: 2026-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-29

Study Completion Date

2026-01-21

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.

Detailed Description

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Conditions

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Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Patients with Non- Small Cell Lung Cancer - NSCLC

Group Type OTHER

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

Intervention Type OTHER

* 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).

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Claudius Regaud

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Larrey

Toulouse, , France

Site Status

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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23 POUM 02

Identifier Type: -

Identifier Source: org_study_id

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