LIquid BIopsies in Patients Presenting Non-small Cell Lung Cancer
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Registration Number
- NCT02511288
- Lead Sponsor
- Centre Leon Berard
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
COHORT 1<br><br>Inclusion Criteria:<br><br> - Patients with histologically confirmed advanced non-small-cell lung carcinoma (stage<br> IIIB/IV) regardless of the mutation status<br><br> - Inclusion at the time of diagnostic<br><br> - Realization of tumor biopsy at the institution (Centre Léon Bérard) or outside the<br> institution with an available histopathological report<br><br> - Age = 18 years<br><br> - Covered by a health insurance<br><br> - Signed consent<br><br>Exclusion Criteria:<br><br> - Patients treated before their liquid biopsy<br><br>COHORT 2 Inclusion criteria<br><br> - Patients with histologically confirmed advanced non-small-cell lung carcinoma (stage<br> IIIB/IV) with one of the following molecular anomalies: Epidermal Growth Factor<br> Receptor (EGFR), B-Raf proto oncogene (BRAF) or Human Epidermal Growth Factor<br> Receptor-2 (HER2) mutations, Anaplatsic Lymphoma Kinase (ALK) or ROS porto-oncogene<br> 1 (ROS1) translocation, Mesenchymal-epithelial transition factor (MET)<br> amplification, RET rearrangement.<br><br> - Inclusion at the time of diagnosis<br><br> - Realization of tumor biopsy at the institution (Centre Léon Bérard) or outside the<br> institution with an available histopathological report<br><br> - Age = 18 years<br><br> - Covered by a health insurance<br><br> - Signed consent<br><br>COHORT 3 Inclusion criteria<br><br> - Patients with histologically confirmed advanced non-small-cell lung carcinoma (stage<br> IIIB/IV) whatever the mutational or PD-L1 status.<br><br> - Inclusion at the time of immunotherapy treatment initiation (1st or 2nd line)<br><br> - Realization of tumor biopsy at the institution (Centre Léon Bérard) or outside the<br> institution with an available histopathological report<br><br> - Age = 18 years<br><br> - Covered by a health insurance<br><br> - Signed consent<br><br>Exclusion criteria<br><br> - Initiation of immunotherpy before their liquid biopsy
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Identification of the genetic profile in advanced or metastatic NSCLC patients using liquid biopsies (circulating tumoral DNA)
- Secondary Outcome Measures
Name Time Method Identification of genetic biomarkers (or molecular profiles) having a potential predictive value in the treatments response;Detection of the ALK and ROS1 genes translocations in the circulating DNA;Evaluation of the liquid biopsies role in the tumoral monitoring;Evaluation of genomic and transcriptomic factors detectable in the plasma, associated to the immunotherapy response;Evaluation of the spatial and temporal tumor heterogeneity under targeted therapy treatment;Evaluation of the miRNAs' expression in plasma as an epigenetic factor associated to treatments response;Circulating tumoral cells isolation and analysis to determine the role of non-genomic and/or phenotypic factors in the treatments response.;Evaluation of the resistance mechanisms to targeted therapies