Impact of Circadian Rhythm on the Spread of Circulating Tumor Cells in Lung Cancer Patients - Clinical Trial for Lung Cancer | NCT05988970

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Primary Purpose

Status

Not yet recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

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

About this trial

This is an interventional other trial for Lung Cancer focused on measuring Circadian rhythm, Circulating tumor cells, CTC, CellSearch, ParSortix

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

Hôpital Larrey
Institut Universitaire du Cancer de Toulouse - Oncopole

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Patients with Non- Small Cell Lung Cancer - NSCLC

Arm Description

Outcomes

Primary Outcome Measures

Presence of CTCs detected with the CellSearch technique.

Secondary Outcome Measures

Quantification of CTCs by the CellSearch technique and expressed in number of cells / millilitre of blood.

Quantification of CTCs by the ParSortix technique and expressed in number of cells / millilitre of blood.

Objective response defined as complete or partial response.

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.

Full Information

NCT ID

NCT05988970

First Posted

August 3, 2023

Last Updated

August 3, 2023

Sponsor

Institut Claudius Regaud

1. Study Identification

Unique Protocol Identification Number

NCT05988970

Brief Title

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

Acronym

SLEEP_CTC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 2023 (Anticipated)

Primary Completion Date

September 2024 (Anticipated)

Study Completion Date

September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut Claudius Regaud

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Cancer

Keywords

Circadian rhythm, Circulating tumor cells, CTC, CellSearch, ParSortix

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients with Non- Small Cell Lung Cancer - NSCLC

Arm Type

Other

Intervention Type

Other

Intervention Name(s)

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

Intervention Description

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 Outcome Measure Information:

Title

Presence of CTCs detected with the CellSearch technique.

Time Frame