Lung CancerNCT02420405
Mutation Detection of EBUS-TBNA Specimens Using NGS
A study testing Routine gene testing and Next-generation sequencing in people with Lung Cancer, run by Jiayuan Sun at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Routine gene testing and Next-generation sequencing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 4. There exist at least one lesions that can be obtained by EBUS-TBNA.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mutation Detection of Small Specimens Obtained by Endobronchial Ultrasound Transbronchial Needle Aspiration in Advanced Nonsquamous Non-small Cell Lung Cancer Using Next-generation Sequencing
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.
Read the 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
- Being tested
- Routine gene testing, Next-generation sequencing
- Keywords
- Gene testing, Endobronchial ultrasound (EBUS), Next-generation sequencing (NGS), Small biopsies
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine gene testingProcedure or surgery
For those diagnosed with nonsquamous NSCLC, routine gene testing including EGFR, ROS1 and ALK will be performed.
Next-generation sequencingProcedure or surgery
For those diagnosed with nonsquamous NSCLC and have done routine gene testing, NGS will be perform on those that have adequate rest tissues.
| Study group | Role | What they receive |
|---|---|---|
| Routine gene testing | Placebo comparator | Routine gene testing of EGFR, ROS1 and ALK will be performed on those diagnosed with nonsquamous NSCLC. Receives: 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. Receives: Procedure: Next-generation sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Values of gene testing between routine method and NGS in EBUS-TBNA specimens
Measured: Up to one and a half years
Secondary outcomes (1)
The quantity of EBUS-TBNA samples adequate for NGS.
Measured: Up to one and a half years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionJul 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiayuan Sun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jiayuan Sun, Shanghai Chest Hospital
- Investigators
- Jiayuan Sun, MD,PhD, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02420405
- Sponsor's protocol ID
- SHCHE201502
- Status last verified
- Feb 2017
- First submitted
- 25 Mar 2015
- Last updated
- 16 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 25377908Wahidi 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.
PubMed 26402427Folch 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.
PubMed 24128714Coco 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.
PubMed 25495923Marchetti 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.
PubMed 22848739
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mutation Detection of Small Specimens Obtained by Endobronchial Ultrasound Transbronchial Needle Aspiration in Advanced Nonsquamous Non-small Cell Lung Cancer Using Next-generation Sequencing
- ClinicalTrials.gov ID
- NCT02420405
- Acronym / sponsor ID
- SHCHE201502
- Conditions
- Lung Cancer
- Keywords
- Gene testing, Endobronchial ultrasound (EBUS), Next-generation sequencing (NGS), Small biopsies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Jiayuan SunUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 17 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine gene testing | Placebo comparator | Procedure: Routine gene testingRoutine gene testing of EGFR, ROS1 and ALK will be performed on those diagnosed with nonsquamous NSCLC. |
| Next-generation sequencing | Experimental | Procedure: Next-generation sequencingRoutine gene testing was performed in those diagnosed with nonsquamous NSCLC. NGS will be performed on these that have adequate rest tissues. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
- 4. There exist at least one lesions that can be obtained by EBUS-TBNA.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine gene testingFor those diagnosed with nonsquamous NSCLC, routine gene testing including EGFR, ROS1 and ALK will be performed. | Procedure or surgery | Routine gene testing |
| Next-generation sequencingFor those diagnosed with nonsquamous NSCLC and have done routine gene testing, NGS will be perform on those that have adequate rest tissues. | Procedure or surgery | Next-generation sequencing |
Primary outcome
Values of gene testing between routine method and NGS in EBUS-TBNA specimens
Time frame: Up to one and a half years
1 secondary outcome
The quantity of EBUS-TBNA samples adequate for NGS.
Time frame: Up to one and a half years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2017.
- Background: PubMed 25377908van 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.
- Background: PubMed 26402427Wahidi 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.
- Background: PubMed 24128714Folch 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.
- Background: PubMed 25495923Coco 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.
- Background: PubMed 22848739Marchetti 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiayuan Sun, MD,PhD principal investigator
Shanghai Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine gene testing and Next-generation sequencing in people with Lung Cancer, run by Jiayuan Sun at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Values of gene testing between routine method and NGS in EBUS-TBNA specimens (time frame: Up to one and a half years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02420405, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2017.