Clinical trial · Interventional
Role of Rapid On-site Evaluation for Mutational Analysis of EBUS-TBNA Specimens
Mutational Analysis of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) Specimens in Patients With Advanced Non-small Cell Lung Cancer: a Randomized Trial of Rapid On-site Evaluation
NCT01799382CI-TRIAL-00015796completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of the study is to determine if rapid on-site evaluation of EBUS-TBNA samples can increase the percentage of patients with advanced non-squamous non-small cell lung cancer in whom both pathologic subtyping and mutational analysis are obtained.
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 |
|---|---|---|---|
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EBUS-TBNA | Device | — | UNRESOLVED |
| Rapid on-site evaluation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- EBUS-TBNA + Rapid on-site evaluation
- description
- Patients in this arm will undergo rapid-on site evaluation of samples obtained with EBUS-TBNA
- interventionNames
- Other: Rapid on-site evaluation
- Device: EBUS-TBNA
- type
- ACTIVE_COMPARATOR
- label
- EBUS-TBNA
- description
- Patients in this arm will undergo EBUS-TBNA without rapid on-site evaluation
- interventionNames
- Device: EBUS-TBNA
Primary outcomes (1)
- measure
- Mutational analysis of epidermal growth factor receptor (EGFR), K-ras, and ALK (anaplastic lymphoma kinase) genes
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years * Suspected hilar or mediastinal lymph node metastasis from lung cancer Exclusion Criteria: * Pregnancy * Uncontrolled coagulopathy * Refusal to sign informed consent
References
Publications (1)
- DERIVEDTrisolini R, Cancellieri A, Tinelli C, de Biase D, Valentini I, Casadei G, Paioli D, Ferrari F, Gordini G, Patelli M, Tallini G. Randomized Trial of Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration With and Without Rapid On-site Evaluation for Lung Cancer Genotyping. Chest. 2015 Dec;148(6):1430-1437. doi: 10.1378/chest.15-0583. PMID 26158441