Clinical trial · Interventional
Mutation Detection of EBUS-TBNA Specimens Using NGS
Mutation Detection of Small Specimens Obtained by Endobronchial Ultrasound Transbronchial Needle Aspiration in Advanced Nonsquamous Non-small Cell Lung Cancer Using Next-generation Sequencing
NCT02420405CI-TRIAL-00026009completedN/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 objective of the study was to compare the value of routine gene testing and next-generation sequencing (NGS) in detecting gene mutations of small specimens obtained by endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) and get the knowledge of how many EBUS-TBNA samples were adequate for NGS.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Next-generation sequencing | Procedure | — | UNRESOLVED |
| Routine gene testing | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Routine gene testing
- description
- Routine gene testing of EGFR, ROS1 and ALK will be performed on those diagnosed with nonsquamous NSCLC.
- interventionNames
- Procedure: Routine gene testing
- type
- EXPERIMENTAL
- label
- Next-generation sequencing
- description
- Routine gene testing was performed in those diagnosed with nonsquamous NSCLC. NGS will be performed on these that have adequate rest tissues.
- interventionNames
- Procedure: Next-generation sequencing
Primary outcomes (1)
- measure
- Values of gene testing between routine method and NGS in EBUS-TBNA specimens
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients who are suspected with nonsquamous non-small cell lung cancer according to the clinical, lab examination and imaging data and had never been diagnosed as primary lung cancer before will be enrolled into the study. 2. The clinical stage of the patients should be in stage IIIA-IV judged by the imaging data and can't receive surgery initially. 4\. There exist at least one lesions that can be obtained by EBUS-TBNA. Exclusion Criteria: 1. The patient is highly suspected to benign lesion, small cell lung cancer and squamous cell carcinoma according to the clinical data. 2. Surgery was considered to be the primary treatment. 3. Patients who are diagnosed with lung cancer and received treatment with drugs or recurrent with lung cancer will be excluded. 4. Severe cardiopulmonary dysfunction and other indications that can't tolerate bronchoscopy.
References
Publications (5)
- BACKGROUNDvan der Heijden EH, Casal RF, Trisolini R, Steinfort DP, Hwangbo B, Nakajima T, Guldhammer-Skov B, Rossi G, Ferretti M, Herth FF, Yung R, Krasnik M; World Association for Bronchology and Interventional Pulmonology, Task Force on Specimen Guidelines. Guideline for the acquisition and preparation of conventional and endobronchial ultrasound-guided transbronchial needle aspiration specimens for the diagnosis and molecular testing of patients with known or suspected lung cancer. Respiration. 2014;88(6):500-17. doi: 10.1159/000368857. Epub 2014 Nov 5. PMID 25377908
- BACKGROUNDWahidi MM, Herth F, Yasufuku K, Shepherd RW, Yarmus L, Chawla M, Lamb C, Casey KR, Patel S, Silvestri GA, Feller-Kopman DJ. Technical Aspects of Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration: CHEST Guideline and Expert Panel Report. Chest. 2016 Mar;149(3):816-35. doi: 10.1378/chest.15-1216. Epub 2016 Jan 12. PMID 26402427
- BACKGROUNDFolch E, Yamaguchi N, VanderLaan PA, Kocher ON, Boucher DH, Goldstein MA, Huberman MS, Kent MS, Gangadharan SP, Costa DB, Majid A. Adequacy of lymph node transbronchial needle aspirates using convex probe endobronchial ultrasound for multiple tumor genotyping techniques in non-small-cell lung cancer. J Thorac Oncol. 2013 Nov;8(11):1438-1444. doi: 10.1097/JTO.0b013e3182a471a9. PMID 24128714
- BACKGROUNDCoco S, Truini A, Vanni I, Dal Bello MG, Alama A, Rijavec E, Genova C, Barletta G, Sini C, Burrafato G, Biello F, Boccardo F, Grossi F. Next generation sequencing in non-small cell lung cancer: new avenues toward the personalized medicine. Curr Drug Targets. 2015;16(1):47-59. doi: 10.2174/1389450116666141210094640. PMID 25495923
- BACKGROUNDMarchetti A, Del Grammastro M, Filice G, Felicioni L, Rossi G, Graziano P, Sartori G, Leone A, Malatesta S, Iacono M, Guetti L, Viola P, Mucilli F, Cuccurullo F, Buttitta F. Complex mutations & subpopulations of deletions at exon 19 of EGFR in NSCLC revealed by next generation sequencing: potential clinical implications. PLoS One. 2012;7(7):e42164. doi: 10.1371/journal.pone.0042164. Epub 2012 Jul 27.