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

Lung Cancer Clinical Trial

— SLEEP_CTC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05988970
• Other study ID #: 23 POUM 02
• Status: Recruiting
• Phase: N/A
• Start date: January 29, 2024
• Est. completion date: September 2025

Study information

• Verified date: January 2024
• Source: Institut Claudius Regaud
• Contact: Carlos GOMEZ ROCA
• Phone: 05 31 15 51 08
• Email: gomez-roca.carlos[@]iuct-oncopole.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: September 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Neoplastic Cells, Circulating

Intervention

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).

Locations

Country	Name	City	State
France	Hôpital Larrey	Toulouse
France	Institut Universitaire du Cancer de Toulouse - Oncopole	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Institut Claudius Regaud

Country where clinical trial is conducted

France, 

Outcome

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