Clinical trial NCT06228508: Molecular Diagnosis of Lung Cancer Via Bronchoscopy: The Significance of Bronchial Liquid Biopsy (ctDNA and ctRNA)
Official title: Molecular Diagnosis of Lung Cancer Via Bronchoscopy: The Significance of Bronchial Liquid Biopsy (ctDNA and ctRNA)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Non Small Cell Lung Cancer
Keywords: Bronchial ctDNA
Bronchial ctRNA
Bonrchoscopy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-01-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients Undergoing Bronchoscopy for Diagnostic Evaluation or Follow-up of Lung Cancer

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Patients Referred for Bronchoscopy at TNN or PSL for Diagnostic Evaluation or Follow-up of Known or Suspected Lung Cancer.
* Age \>18 years.
* Informed, Written, and Signed Consent.
* Participants must be covered by a national health insurance scheme.

Exclusion Criteria:

* Patient Refusal
* Patient benefiting from legal protection measure

Primary outcomes:
measure: Sensibility of bronchial ctDNA
timeFrame: Through study completion, an average of 6 month
Secondary outcomes:
measure: Diagnostic Performance of ctDNA Molecular Testing
timeFrame: Through study completion, an average of 6 month
measure: Diagnostic Performance of ctDNA Molecular Testing
timeFrame: Through study completion, an average of 6 month
measure: Comparing Turnaround Time of Molecular Biology Results
timeFrame: Through study completion
measure: Comparison of Performance between Bronchial ctDNA and Blood ctDNA when Available
timeFrame: Through study completion, an average of 6 month
measure: Evaluating Analysis Modalities in Liquid Biopsy Techniques
timeFrame: Through study completion, an average of 6 month
measure: Subgroup Analysis of Diagnostic Performance of Bronchial ctDNA and ctRNA
timeFrame: Through study completion, an average of 6 month
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de Pneumologie et Oncologie Thoracique - Hôpital Tenon
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Vincent FALLET, MD
role: PRINCIPAL_INVESTIGATOR
References: