Clinical trial · Interventional
Optimizing Endobronchial Ultrasound Sampling for Molecular Markers for NSCLC
OPTimizing Endobronchial Ultrasound Sampling In Suspected Non Small Cell Lung Cancer for Molecular Markers : A Pragmatic Randomized Controlled TriaL
- 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)
In this monocentric randomized controlled trial, 120 potential non small cell lung cancer (NSCLC) patients for which tissue diagnosis and material for next generation sequencing (NGS) is required for clinical management will be approached the day of their endobronchial ultrasound to participate in the study. They will be randomized to 2 vs 3 passes/lymph node and will all undergo liquid biopsy. The co-primary outcomes are 1)the rate of obtention of adequate material for NGS testing with 2 vs 3 passes/lymph node and 2)the percentage of patients for which liquid biopsy allows to identify clinically pertinent findings not available from tissue biopsy
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Circulating Tumor Cell | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endobronchial ultrasound | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 2 passes per target on EBUS
- interventionNames
- Procedure: Endobronchial ultrasound
- type
- EXPERIMENTAL
- label
- 3 passes per target on EBUS
- interventionNames
- Procedure: Endobronchial ultrasound
Primary outcomes (2)
- measure
- Rate of obtention of adequate material for NGS testing with 2 vs 3 passes/lymph node
- timeFrame
- At recruitment completion (expected time 2 years), all cell blocks will be reviewed by the blinded pathologist to assess adequacy rate for NGS testing
- description
- Cell block will be reviewed by a blinded pathologist to determine the percentage of tumor cells within the sample by increment of 5%. More than 10% of tumor cell will be considered adequate.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Suspected or confirmed NSCLC requiring tissue sample for NGS testing to guide clinical management * Presence of at least 2 targets accessible by EBUS or EUS suspicious of malignancy (primary tumor, lymph node \> 10mm or with Standardized Uptake Value (SUV) \> 2.5) Exclusion Criteria: * Other modality then EBUS judged preferable by treating physician to obtain tumoral tissue for NGS testing
References
Publications (0)
Data not yet available