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Trial Title:
Impact of Circadian Rhythm on the Spread of Circulating Tumor Cells in Lung Cancer Patients
NCT ID:
NCT05988970
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Neoplastic Cells, Circulating
Conditions: Keywords:
Circadian rhythm
Circulating tumor cells
CTC
CellSearch
ParSortix
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Blood samples will be collected at two times before the treatment initiation:
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).
Arm group label:
Patients with Non- Small Cell Lung Cancer - NSCLC
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.
Criteria for eligibility:
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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Hôpital Larrey
Address:
City:
Toulouse
Country:
France
Status:
Recruiting
Contact:
Last name:
Julien MAZIERES
Phone:
05 67 77 14 86
Email:
mazieres.j@chu-toulouse.fr
Facility:
Name:
Institut Universitaire du Cancer de Toulouse - Oncopole
Address:
City:
Toulouse
Country:
France
Status:
Recruiting
Contact:
Last name:
Carlos GOMEZ ROCA
Phone:
05 31 15 51 08
Email:
gomez-roca.carlos@iuct-oncopole.fr
Start date:
January 29, 2024
Completion date:
September 2025
Lead sponsor:
Agency:
Institut Claudius Regaud
Agency class:
Other
Source:
Institut Claudius Regaud
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05988970
