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

January 23, 2026 updated by: Institut Claudius Regaud

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France
        • Hôpital Larrey
      • Toulouse, France
        • Institut Universitaire du Cancer de Toulouse - Oncopole

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Presence of CTCs detected with the CellSearch technique.
Time Frame: 12 months after the end of inclusions
12 months after the end of inclusions

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantification of CTCs by the CellSearch technique and expressed in number of cells / millilitre of blood.
Time Frame: 12 months after the end of inclusions
12 months after the end of inclusions
Quantification of CTCs by the ParSortix technique and expressed in number of cells / millilitre of blood.
Time Frame: 12 months after the end of inclusions
12 months after the end of inclusions
Objective response defined as complete or partial response.
Time Frame: 12 months after the end of inclusions
Response will be assessed according to the clinician's judgment.
12 months after the end of inclusions
Progression-free survival (PFS) defined as the time between the date of inclusion and the date of first progression or death.
Time Frame: 12 months after the end of inclusions
12 months after the end of inclusions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2024

Primary Completion (Actual)

January 21, 2026

Study Completion (Actual)

January 21, 2026

Study Registration Dates

First Submitted

August 3, 2023

First Submitted That Met QC Criteria

August 3, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 23, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23 POUM 02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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