Clinical trial · Observational
Genotyping of Ebus-tbna Supernant Cell-free Dna in Nsclc
Molecular Analysis of the Surnantant of Echoguidated Bronchoscopic Cytopunctions in Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The wide uptake of "liquid biopsy" diagnostics in the care of advanced cancer patients highlights the desire for improved access to tumor allowing accurate tumor genotyping (1). Genotyping of plasma cfDNA is now routine for detection of EGFR driver mutations at diagnosis of NSCLC, or for detection of the EGFR T790M mutation after TKI resistance, and is an emerging approach for the detection of other drivers (HER2 or BRAF mutations, ALK or ROS1 fusions…) (2) or the estimation of tumor mutation burden (TMB) (3). However, the most sensitive plasma genotyping platforms still have a sensitivity of only 70%-80%, such that a negative result requires tissue biopsy confirmation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Molecular analysis of surnatant | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Identified mutation
- description
- The sensitivity of supernatant to identify the mutations detected on cell block (Gold standard).
- interventionNames
- Other: Molecular analysis of surnatant
- label
- Non identified mutation
- description
- The sensitivity of supernatant to identify the mutations detected on cell block (Gold standard).
- interventionNames
- Other: Molecular analysis of surnatant
Primary outcomes (1)
- measure
- main aim of the study
- timeFrame
- 18 months
- description
- to investigate the sensitivity of sfDNA genotyping in various clinical settings and to compare it to cell block
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years-old * Patients planned for an EBUS-TBNA for 1. Suspicion of stage IV lung cancer (PET+ mediastinal node(s)) (Cohort 1) 2. Stage IV NSCLC with an EGFR, BRAF, HER2, MET mutation or ALK, RET or ROS1 rearranged NSCLC and acquired resistance to targeted therapy (Cohort 2) * Performance status 0-3 * Informed consent Exclusion Criteria: * Refusal to participate * Patient under legal tutelage
References
Publications (0)
Data not yet available