Clinical trial · Observational
One Step Nucleic Acid Amplification in Endobronchial Ultrasound-guided Needle Aspiration Samples
A Molecular Test for Rapid On-site Evaluation in EBUS-TBNAsamples of Lung Cancer Patients
NCT02157857CI-TRIAL-00014792unknownClinicalTrials.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 aim of our study is to investigate if CK19 mRNA-detection via OSNA can accurately detect lymph node metastases in lung cancer patients using EBUS-TBNA samples.
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 Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- One step nucleic acid amplification of Cytokeratin 19 mRNA
- timeFrame
- 6 months
- description
- One step nucleic acid amplification of Cytokeratin 19 mRNA, copy number detection
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 95 Years
Show eligibility criteria text
Inclusion Criteria: * CT-scan suspicious for lung cancer, * enlarged mediastinal lymph nodes (\>10 mm), * EBUS-TBNA to be performed, * age: 18-99 years Exclusion Criteria: * age: \<18 years
References
Publications (4)
- BACKGROUNDYasufuku K, Pierre A, Darling G, de Perrot M, Waddell T, Johnston M, da Cunha Santos G, Geddie W, Boerner S, Le LW, Keshavjee S. A prospective controlled trial of endobronchial ultrasound-guided transbronchial needle aspiration compared with mediastinoscopy for mediastinal lymph node staging of lung cancer. J Thorac Cardiovasc Surg. 2011 Dec;142(6):1393-400.e1. doi: 10.1016/j.jtcvs.2011.08.037. Epub 2011 Oct 2. PMID 21963329
- BACKGROUNDInoue M, Hiyama K, Nakabayashi K, Morii E, Minami M, Sawabata N, Shintani Y, Nakagiri T, Susaki Y, Maeda J, Higashiyama M, Okami J, Yoshida Y, Ding J, Otomo Y, Okumura M. An accurate and rapid detection of lymph node metastasis in non-small cell lung cancer patients based on one-step nucleic acid amplification assay. Lung Cancer. 2012 Dec;78(3):212-8. doi: 10.1016/j.lungcan.2012.08.018. Epub 2012 Sep 29. PMID 23026640
- BACKGROUNDBabar M, Madani R, Thwaites L, Jackson PA, Devalia HL, Chakravorty A, Irvine TE, Layer GT, Kissin MW. A differential intra-operative molecular biological test for the detection of sentinel lymph node metastases in breast carcinoma. An extended experience from the first U.K. centre routinely offering the service in clinical practice. Eur J Surg Oncol. 2014 Mar;40(3):282-8. doi: 10.1016/j.ejso.2013.10.030. Epub 2013 Nov 21. PMID 24331309
- DERIVEDOezkan F, Khan AM, Hager T, Freitag L, Christoph D, Darwiche K. OSNA: A Fast Molecular Test Based on CK19 mRNA Concentration for Assessment of EBUS-TBNA Samples in Lung Cancer Patients. Clin Lung Cancer. 2016 May;17(3):198-204. doi: 10.1016/j.cllc.2015.09.001. Epub 2015 Sep 21. PMID 26455862