Molecular Diagnosis of Lung Cancer Via Bronchoscopy: The Significance of Bronchial Liquid Biopsy (ctDNA and ctRNA) - Trial NCT06228508

Timeline & Enrollment

Primary Outcome

Sensibility of bronchial ctDNA

Summary

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 that will include 50 patients.

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