The management of lung cancer is a major public health challenge. Molecular anomaly testing is recommended from the early stages for optimal and personalized care of all lung adenocarcinomas and non-smoker lung cancers. The search for these anomalies relies on increasingly advanced and sensitive analysis techniques, particularly Next-Generation Sequencing (NGS), which can simultaneously detect various molecular abnormalities in both DNA and RNA, including point mutations, complex mutations, rearrangements, and amplifications. These techniques are predominantly performed on biopsy specimens embedded in paraffin. However, these biopsies may require invasive and sometimes iatrogenic procedures, and their feasibility, quantity, and quality of the samples can be limited. The turnaround time for analysis results from the time of biopsy is typically around 2 to 3 weeks. In recent years, alongside the improvement in the sensitivity of molecular analysis techniques, liquid biopsy has emerged as a valuable approach, particularly in the analysis of circulating tumor DNA (ctDNA). ctDNA is a non-invasive diagnostic biomarker that has been validated for detecting targetable molecular anomalies similar to those detected by "conventional" biopsies. ctDNA can be detected in plasma through a simple blood draw, as well as in cerebrospinal fluid, urine, saliva, or any other "liquid" sample from the patient. The concordance between mutations identified in the tumor and those detected in the blood exceeds 90% specificity in numerous studies. However, the sensitivity of ctDNA detection varies depending on the stage of the disease and the sensitivity of the detection technique used. The utility of bronchial ctDNA is currently underexplored. However, there is a rationale for investigating ctDNA as close as possible to the cancerous lesion at the bronchial level. Bronchial ctDNA could play a role in molecular diagnosis for distal lesions not visible through endoscopy and could also help reduce costs and turnaround time for molecular diagnosis in larger tumors. The objective of this study is to evaluate the utility of liquid biopsy (ctDNA and ctRNA) during bronchoscopy in the molecular diagnosis and management of bronchial carcinomas. This is a prospective multicenter French study.
Study Type
OBSERVATIONAL
Enrollment
79
Service de Pneumologie et Oncologie Thoracique - Hôpital Tenon
Paris, France
Sensibility of bronchial ctDNA
Calculation of the sensitivity of bronchial ctDNA for the molecular diagnosis of lung cancers
Time frame: Through study completion, an average of 6 month
Diagnostic Performance of ctDNA Molecular Testing
Specificity; Positive Predictive Value; Negatice Predictive Value
Time frame: Through study completion, an average of 6 month
Diagnostic Performance of ctDNA Molecular Testing
Sensibility; Specificity; Positive Predictive Value; Negatice Predictive Value
Time frame: Through study completion, an average of 6 month
Comparing Turnaround Time of Molecular Biology Results
Time of Molecular Biology Results for Bronchial ctDNA and ctRNA (versus Standard Histology)
Time frame: Through study completion
Comparison of Performance between Bronchial ctDNA and Blood ctDNA when Available
Calculation of the concordance rate between these 2 methods.
Time frame: Through study completion, an average of 6 month
Evaluating Analysis Modalities in Liquid Biopsy Techniques
Description of the methods of the analysis technique using the supernatant vs pellet
Time frame: Through study completion, an average of 6 month
Subgroup Analysis of Diagnostic Performance of Bronchial ctDNA and ctRNA
Description of the mutations found in the lung cancers
Time frame: Through study completion, an average of 6 month
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