In clinical trials, patients are selected according to strict eligibility criteria (inclusion and exclusion criteria). These criteria aim to ensure homogeneity within the trial population, but may omit patients with specific characteristics, comorbidities or co-medications. Indeed, patients of advanced age, with comorbidities or brain metastases, who are frequently encountered in clinical practice, are often excluded from clinical trials. Real-life data in oncology play a vital role in assessing the efficacy of therapies and therapeutic strategies, complementing data from controlled clinical trials. They make it possible to analyze a larger population and take into account multiple variables such as patient history, co-medications and comorbidities, but also to analyze efficacy and toxicity data in populations not represented in clinical trials. The establishment of a prospective cohort including various stages and histologies will make it possible to set up a platform of available data, including a maximum of data linked to the patient, his tumor and his treatments, collected longitudinally until the patient's death (or the end of the study). In parallel with this cohort, the project aims to set up a longitudinal plasmatheque (from diagnosis to death, or at the end of the study), as well as a tumorotheque (samples systematically stored as part of care by the CHU tumorotheque, and for which patient consent allows their use in research depending on the material available) for patients with available tumor samples. This will enable the construction of ancillary projects to validate research hypotheses, for example concerning the identification of mechanisms of resistance to therapies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
730
Patients will be sampled from 2 x 8 mL blood tubes (EDTA tubes)
Patients will be sampled from 1 x 8 mL PBMC
Patients will be sampled from 1 x 8 mL of blood with Paxgene Tube
Regarding the ancillary study, as part of the care, patients are biopsied at diagnosis and during relapse(s). For metastatic patients with multiple sites, one site (the most accessible) is chosen and biopsied in interventional radiology or pulmonology. The material used is: 17-18G biopsy needle / Sampling chamber volume of 0.01 cm³ to 0.02 cm³. For a standard biopsy as part of the care, 3 samples are taken (total volume of 0.03 cm³ to 0.06 cm³). Inclusion in the ancillary study would add one sample using the same biopsy path, resulting in an additional volume of 0.01 cm³ to 0.02 cm³. In the case of a complex biopsy, no additional sampling related to the research will be performed.
CHU Nantes
Nantes, France
RECRUITINGOverall survival
Overall survival will be defined as the time elapsed between the date of the initial diagnosis of lung cancer and the date of death, regardless of the cause. Patients still alive at the end of the follow-up period will complete their participation in the cohort.
Time frame: up to 5 years
Describe the care pathway for patients with lung cancer. Assess the time intervals between different steps in the initial management of lung cancer.
The care pathway will be described through the collection of dates (surgery, radiotherapy, presentation at multidisciplinary consultation meetings, etc.) and types of medical consultations.
Time frame: up to 5 years
Evaluate the return to work for patients of working age who have been treated for lung cancer.
Proportion of patients who returned to work after treatment, measurement of the average time taken, and factors associated with the return to work.
Time frame: up to 5 years
Identify specific biomarkers of lung cancer cells (primary tumors or metastatic tissues) in comparison to healthy lung tissues.
Quantitative comparison and characterization of biomarkers (extracellular vesicles and miRNA signatures) between tumor tissues and non-cancerous tissues.
Time frame: up to 5 years
Evaluate the prognostic and predictive value of circulating biomarkers at diagnosis and during systemic treatments.
Association between levels of circulating biomarkers and overall survival as well as treatment response.
Time frame: up to 5 years
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