NCT02420405

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Jiayuan Sun · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Some gene mutations can direct individualized treatment. The routine gene testing of EGFR, ROS1 and ALK is direct sequencing, Reverse transcription quantitative real-time polymerase chain reaction (RT-QPCR) and fluorescent in situ hybridization (FISH) or immunohistochemistry (IHC). Next-generation sequencing (NGS) is a new technique, which is more sensitive than routine techniques. So we decided to compare the value of gene testing between routine method and NGS in EBUS-TBNA specimens and get the knowledge of how many EBUS-TBNA samples were adequate for NGS. The study was designed as a prospective and single center study. Seventy patients will be enrolled into the study and the clinical data of the patients, including his smoke history, cancer history, occupation exposure and so on, will be collected and recorded in a case report form. For the patients recruited in the study, the lymph nodes suspected to be malignant will be obtained by EBUS-TBNA. Samples will be sent to Pathology Department of Shanghai Chest Hospital and will be processed with paraffin-embedded, and for those diagnosed with nonsquamous NSCLC, routine gene testing of EGFR, ROS1 and ALK will be performed. And the rest tissues will be extracted with DNA and performed gene mutations using NGS for these qualified DNA samples.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
PROCEDURE	Routine gene testing	For those diagnosed with nonsquamous NSCLC, routine gene testing including EGFR, ROS1 and ALK will be performed.
PROCEDURE	Next-generation sequencing	For those diagnosed with nonsquamous NSCLC and have done routine gene testing, NGS will be perform on those that have adequate rest tissues.

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-07-01
• Completion: 2016-07-01
• First posted: 2015-04-17
• Last updated: 2017-02-16

Locations

1 site across 1 country: China