Lung CancerSLEEP_CTCNCT05988970
Impact of Circadian Rhythm on the Spread of Circulating Tumor Cells in Lung Cancer Patients
A study testing Blood samples will be collected at two times before the treatment initiation: in people with Lung Cancer, run by Institut Claudius Regaud at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Blood samples will be collected at two times before the treatment initiation:
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesFrance
- Study dates
- 29 Jan 2024to 21 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Larrey
Toulouse
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse
About this study
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.
- Conditions
- Lung Cancer
- Being tested
- Blood samples will be collected at two times before the treatment initiation:
- Keywords
- Circadian rhythm, Circulating tumor cells, CTC, CellSearch, ParSortix
- Medical subject headings
- Lung Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Patients with Non- Small Cell Lung Cancer - NSCLC | Other | Not described Receives: Other: Blood samples will be collected at two times before the treatment initiation: |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of CTCs detected with the CellSearch technique.
Measured: 12 months after the end of inclusions
Secondary outcomes (4)
Quantification of CTCs by the CellSearch technique and expressed in number of cells / millilitre of blood.
Measured: 12 months after the end of inclusions
Quantification of CTCs by the ParSortix technique and expressed in number of cells / millilitre of blood.
Measured: 12 months after the end of inclusions
Objective response defined as complete or partial response.
Response will be assessed according to the clinician's judgment.
Measured: 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.
Measured: 12 months after the end of inclusions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start29 Jan 2024
- Primary completion21 Jan 2026
- Study completion21 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988970
- Sponsor's protocol ID
- 23 POUM 02
- Acronym
- SLEEP_CTC
- Status last verified
- Jan 2026
- First submitted
- 3 Aug 2023
- Last updated
- 27 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Circadian Rhythm on the Spread of Circulating Tumor Cells in Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT05988970
- Acronym / sponsor ID
- SLEEP_CTC / 23 POUM 02
- Conditions
- Lung Cancer
- Keywords
- Circadian rhythm, Circulating tumor cells, CTC, CellSearch, ParSortix
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 21 Jan 2026 (actual)
- Study completion
- 21 Jan 2026 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Non- Small Cell Lung Cancer - NSCLC | Other | Other: Blood samples will be collected at two times before the treatment initiation: |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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...)
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Other | Patients with Non- Small Cell Lung Cancer - NSCLC |
Primary outcome
Presence of CTCs detected with the CellSearch technique.
Time frame: 12 months after the end of inclusions
4 secondary outcomes
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
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
Objective response defined as complete or partial response.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood samples will be collected at two times before the treatment initiation: in people with Lung Cancer, run by Institut Claudius Regaud at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of CTCs detected with the CellSearch technique. (time frame: 12 months after the end of inclusions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.