Mutation Detection of EBUS-TBNA Specimens Using NGS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Feasibility of Evaluating Gene Alteration Analysis Using Samples Obtained by EBUS-TBNA in Patients With Lung Cancer

NCT01487603

Lung Cancer

RECRUITING

Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy of NSCLC Patients in China

NCT03059641

Lung Neoplasms Lung Cancer, Nonsmall Cell Adenocarcinoma of Lung +1 more

COMPLETED

A Prospective Study to Evaluate the Consistency of Next-Generation Sequencing(NGS)-Panels by Using Malignant Hydrothorax Form NSCLC

NCT03546452

Malignant Hydrothorax NSCLC

UNKNOWN

NGS-based Comprehensive Genomic ctDNA Panel in NSCLC With Immunotherapy

NCT04636047

Lung Cancer

UNKNOWN

Whether Sputum Can Serve as an Alternative Source for Liquid Biopsy in Patients With Lung Cancer

NCT05034445

NSCLC

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Routine gene testing

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

Group Type PLACEBO_COMPARATOR

Routine gene testing

Intervention Type PROCEDURE

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

Next-generation sequencing

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

Group Type EXPERIMENTAL

Next-generation sequencing

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Routine gene testing

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

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No