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Non Small Cell Lung CancerBiliBroNCT06228508

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

An observational study of Non Small Cell Lung Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Cancer
How many people
79 participants
Where
1 siteFrance
Study dates
2 Feb 2024to 6 Nov 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • Patient Refusal
  • Patient benefiting from legal protection measure

Trial locations and contacts

1 site in 1 country.

France1 site
  • Service de Pneumologie et Oncologie Thoracique - Hôpital Tenon

    Paris, 75020

Other trials in France

About this study

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.

Read more

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.

Keywords
Bronchial ctDNA, Bronchial ctRNA, Bonrchoscopy
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sensibility of bronchial ctDNA

    Calculation of the sensitivity of bronchial ctDNA for the molecular diagnosis of lung cancers

    Measured: Through study completion, an average of 6 month

Secondary outcomes (6)
  1. Diagnostic Performance of ctDNA Molecular Testing

    Specificity; Positive Predictive Value; Negatice Predictive Value

    Measured: Through study completion, an average of 6 month

  2. Diagnostic Performance of ctDNA Molecular Testing

    Sensibility; Specificity; Positive Predictive Value; Negatice Predictive Value

    Measured: 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)

    Measured: Through study completion

  4. Comparison of Performance between Bronchial ctDNA and Blood ctDNA when Available

    Calculation of the concordance rate between these 2 methods.

    Measured: 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

    Measured: 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

    Measured: Through study completion, an average of 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2024
  2. Study start2 Feb 2024
  3. Primary completion7 May 2024
  4. Study completion6 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06228508
Sponsor's protocol ID
APHP231133
Other IDs
IDRCB 2023-A01900-45
Acronym
BiliBro
Status last verified
Aug 2026
First submitted
6 Nov 2023
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Non Small Cell Lung Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensibility of bronchial ctDNA (time frame: Through study completion, an average of 6 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.

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