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OpenTrials
Completed

NCT Number: NCT05988970

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

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Cells, Circulating Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Larrey, Toulouse, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

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).

Primary outcomes

  1. Presence of CTCs detected with the CellSearch technique.

    Time frame: 12 months after the end of inclusions

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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

Sponsors and collaborators

Lead sponsor

Institut Claudius Regaud

Other

Registry information

Acronym: SLEEP_CTC

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2023
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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