Effects of body clock on tumor cell spread in lung cancer patients
Impact of Circadian Rhythm on the Spread of Circulating Tumor Cells in Lung Cancer Patients
This study is testing how the body's natural clock affects the spread of cancer cells in patients with advanced lung cancer to see if timing treatments differently could help.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut Claudius Regaud Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Toulouse and 1 other locations) |
| Trial ID | NCT05988970 on ClinicalTrials.gov |
What this trial studies
This prospective pilot study aims to explore how circadian rhythms influence the spread of circulating tumor cells (CTCs) in patients diagnosed with advanced non-small cell lung cancer (NSCLC). A total of 27 patients will be enrolled and monitored over a 12-month period. Blood samples will be collected from each participant before the initiation of anticancer treatment to analyze the relationship between their biological clock and CTC levels. The study seeks to provide insights into the timing of treatment interventions based on circadian patterns.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with advanced, histologically confirmed NSCLC who are treatment-naïve and hospitalized for treatment initiation.
Not a fit: Patients with small-cell lung cancer or those who have previously received treatment for NSCLC may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective timing of cancer treatments, potentially improving patient outcomes.
How similar studies have performed: While the impact of circadian rhythms on cancer treatment is a growing area of interest, this specific approach focusing on CTCs in NSCLC is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Toulouse and 1 other locations
- Hôpital Larrey — Toulouse, France (Recruiting)
- Institut Universitaire du Cancer de Toulouse - Oncopole — Toulouse, France (Recruiting)
Study contacts
- Study coordinator: Carlos GOMEZ ROCA
- Email: gomez-roca.carlos@iuct-oncopole.fr
- Phone: 05 31 15 51 08
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.