Mutation Detection of EBUS-TBNA Specimens Using NGS

NCT02420405 | Completed DMC

• 1 other identifier: SHCHE201502
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

Keywords

Gene testing; Endobronchial ultrasound (EBUS); Next-generation sequencing (NGS); Small biopsies

Outcome Measures

Primary Outcomes (1)

• Values of gene testing between routine method and NGS in EBUS-TBNA specimens

  Up to one and a half years

Secondary Outcomes (1)

• The quantity of EBUS-TBNA samples adequate for NGS.

  Up to one and a half years

Study Arms (2)

Routine gene testing

PLACEBO COMPARATOR

Routine gene testing of EGFR, ROS1 and ALK will be performed on those diagnosed with nonsquamous NSCLC.

Procedure: Routine gene testing

Next-generation sequencing

EXPERIMENTAL

Routine gene testing was performed in those diagnosed with nonsquamous NSCLC. NGS will be performed on these that have adequate rest tissues.

Procedure: Next-generation sequencing

Interventions

Routine gene testing PROCEDURE

For those diagnosed with nonsquamous NSCLC, routine gene testing including EGFR, ROS1 and ALK will be performed.

Routine gene testing

Next-generation sequencing PROCEDURE

For those diagnosed with nonsquamous NSCLC and have done routine gene testing, NGS will be perform on those that have adequate rest tissues.

Next-generation sequencing

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• The clinical stage of the patients should be in stage IIIA-IV judged by the imaging data and can't receive surgery initially.
• \. There exist at least one lesions that can be obtained by EBUS-TBNA.

You may not qualify if:

• The patient is highly suspected to benign lesion, small cell lung cancer and squamous cell carcinoma according to the clinical data.
• Surgery was considered to be the primary treatment.
• Patients who are diagnosed with lung cancer and received treatment with drugs or recurrent with lung cancer will be excluded.
• Severe cardiopulmonary dysfunction and other indications that can't tolerate bronchoscopy.

Sponsors & Collaborators

• Jiayuan Sun: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Related Publications (5)

• van 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 BACKGROUND

• Wahidi 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 BACKGROUND

• Folch 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 BACKGROUND

• Coco 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 BACKGROUND

• Marchetti 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.

  PMID: 22848739 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Interventions

High-Throughput Nucleotide Sequencing

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sequence Analysis; Genetic Techniques; Investigative Techniques

Study Officials

• Jiayuan Sun, MD,PhD

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Endoscope Department, Shanghai Chest Hospital

Study Record Dates

• First Submitted: March 25, 2015
• First Posted: April 17, 2015
• Study Start: March 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2016
• Last Updated: February 16, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)