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

Non Small Cell Lung Cancer Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06228508
• Other study ID #: APHP231133
• Status: Not yet recruiting
• Start date: February 2024
• Est. completion date: August 2024

Study information

• Verified date: January 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Vincent FALLET, MD
• Phone: +33156016218
• Email: vincent.fallet[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: August 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Non Small Cell Lung Cancer

Locations

Country	Name	City	State
France	Service de Pneumologie et Oncologie Thoracique - Hôpital Tenon	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Diagnostic Performance of ctDNA Molecular Testing	Specificity; Positive Predictive Value; Negatice Predictive Value	Through study completion, an average of 6 month
Secondary	Diagnostic Performance of ctDNA Molecular Testing	Sensibility; Specificity; Positive Predictive Value; Negatice Predictive Value	Through study completion, an average of 6 month
Secondary	Comparing Turnaround Time of Molecular Biology Results	Time of Molecular Biology Results for Bronchial ctDNA and ctRNA (versus Standard Histology)	Through study completion
Secondary	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
Secondary	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
Secondary	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