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

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 Overview

• Status: Completed
• Conditions: Non Small Cell Lung Cancer

• Study Type: Observational
• Enrollment (Actual): 79

Contacts and Locations

Study Locations

• France
  • Paris, France, 75020
    • Service de Pneumologie et Oncologie Thoracique - Hôpital Tenon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients Undergoing Bronchoscopy for Diagnostic Evaluation or Follow-up of Lung Cancer

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Vincent FALLET, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2024
• Primary Completion (Actual): May 7, 2024
• Study Completion (Actual): November 6, 2024

Study Registration Dates

• First Submitted: November 6, 2023
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Actual): January 29, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2026
• Last Update Submitted That Met QC Criteria: August 11, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Bronchial ctDNA; Bronchial ctRNA; Bonrchoscopy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: APHP231133; IDRCB 2023-A01900-45 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No