EGFRdelEx19 and KRAS Exon 2 Mutation Detection in EBUS-TBNA (EGFRdelEx19)
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|ClinicalTrials.gov Identifier: NCT02975752|
Recruitment Status : Completed
First Posted : November 29, 2016
Last Update Posted : November 29, 2016
|Condition or disease||Intervention/treatment|
|Lung Adenocarcinoma Metastatic||Genetic: LC-RT-PCR and NGS|
First-line treatment with afatinib prolongs overall survival in patients with metastatic non-small-cell lung cancer (NSCLC) harboring EGFR exon 19 deletion mutations. Conversely, somatic KRAS mutations are negative predictors for benefit from EGFR-targeting agents. Rapid availability of these biomarker results is mandatory to prevent delayed or inferior treatments.
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is well-established for lung cancer diagnosis and staging. Next generation sequencing (NGS) via targeted resequencing allows simultaneous interrogation for multiple mutations, but has its limitations based on the amount of tumor tissue required and assay times. RT-PCR using Light-Cycler technology (LC-RTPCR) is a rapid and sensitive assay to detect somatic mutations in various tissues from NSCLC patients. The study's aim was to analyze if LC-RTPCR is feasible for rapid EGFRdelEx19 and KRAS Exon 2 mutation detection in EBUS-TBNA samples and to compare results with results obtained via standard NGS mutation analyses.
|Study Type :||Observational|
|Actual Enrollment :||48 participants|
|Official Title:||Rapid and Highly Sensitive EGFRdelEx19 and KRAS Exon 2 Mutation Detection in EBUS-TBNA Specimen of Lymph Node Metastases From Patients With Lung Adenocarcinoma|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||November 2016|
- Genetic: LC-RT-PCR and NGS
highly sensitive PCR vs. multiplex targeted-resequencing
- detection of mutations [ Time Frame: 1 year ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02975752
|Principal Investigator:||Filiz Özkan, MD||Department of Interventional Pneumology|