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

NCT06228508 | Unknown

• 1 other identifier: APHP231133
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer

Keywords

Bronchial ctDNA; Bronchial ctRNA; Bonrchoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Diagnostic Performance of ctDNA Molecular Testing

  Through study completion, an average of 6 month

• Diagnostic Performance of ctDNA Molecular Testing

  Through study completion, an average of 6 month

• Comparing Turnaround Time of Molecular Biology Results

  Through study completion

• Comparison of Performance between Bronchial ctDNA and Blood ctDNA when Available

  Through study completion, an average of 6 month

• Evaluating Analysis Modalities in Liquid Biopsy Techniques

  Through study completion, an average of 6 month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Patient Refusal
• Patient benefiting from legal protection measure

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de Pneumologie et Oncologie Thoracique - Hôpital Tenon

Paris, 75020, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

ctDNA and ctRNA

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Vincent FALLET, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent FALLET, MD

CONTACT

+33156016218; vincent.fallet@aphp.fr

Jacques CADRANEL, PU PH

CONTACT

+33156016218; jacques.cadranel@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: January 29, 2024
• Study Start: February 1, 2024
• Primary Completion: May 1, 2024
• Study Completion: August 1, 2024
• Last Updated: January 29, 2024

Record last verified: 2024-01

Locations

FR (1)