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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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| Measure | Description | Time Frame |
|---|---|---|
| Sensibility of bronchial ctDNA | Calculation of the sensitivity of bronchial ctDNA for the molecular diagnosis of lung cancers | Through study completion, an average of 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Performance of ctDNA Molecular Testing | Specificity; Positive Predictive Value; Negatice Predictive Value | Through study completion, an average of 6 month |
| Diagnostic Performance of ctDNA Molecular Testing |
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Inclusion Criteria:
Exclusion Criteria:
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Patients Undergoing Bronchoscopy for Diagnostic Evaluation or Follow-up of Lung Cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vincent FALLET, MD | Contact | +33156016218 | vincent.fallet@aphp.fr | |
| Jacques CADRANEL, PU PH | Contact | +33156016218 | jacques.cadranel@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Vincent FALLET, MD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Pneumologie et Oncologie Thoracique - Hôpital Tenon | Paris | 75020 | France |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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ctDNA and ctRNA
Sensibility; Specificity; Positive Predictive Value; Negatice Predictive Value
| 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) | Through study completion |
| Comparison of Performance between Bronchial ctDNA and Blood ctDNA when Available | Calculation of the concordance rate between these 2 methods. | 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 | 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 | Through study completion, an average of 6 month |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |