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CompletedNCT06228508BiliBroUpdated Aug 13, 2026

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

An observational study in Non Small Cell Lung Cancer, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
79
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Non Small Cell Lung Cancer

Keywords

  • Bronchial ctDNA
  • Bronchial ctRNA
  • Bonrchoscopy
03

In context

Carcinoma, Non-Small-Cell Lung

6,491 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,633 are open to participants now.

This study's enrollment of 79 is below the median of 161 across 949 observational studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,506 studies on the registry; 1,007 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

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

Exclusion Criteria:

  • Patient Refusal
  • Patient benefiting from legal protection measure
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
79 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Diagnostic Performance of ctDNA Molecular Testing

    Specificity; Positive Predictive Value; Negatice Predictive Value

    Time frame: Through study completion, an average of 6 month

  2. Diagnostic Performance of ctDNA Molecular Testing

    Sensibility; Specificity; Positive Predictive Value; Negatice Predictive Value

    Time frame: Through study completion, an average of 6 month

  3. 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

  4. 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

  5. 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

  6. 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

07

Study locations

1 site
  • Service de Pneumologie et Oncologie Thoracique - Hôpital Tenon
    Paris, 75020, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06228508
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Responsible party
Sponsor
First posted
Jan 29, 2024
Start date
Feb 2, 2024
Primary completion
May 7, 2024
Completion
Nov 6, 2024
Last update
Aug 13, 2026

Study contacts

Vincent FALLET, MD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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