NSCLCNCT03609918
Comprehensive Analysis of Gene Mutation Profile in Chinese NSCLC Patients by Next-generation Sequencing
An observational study of NSCLC, run by Tianjin Medical University Cancer Institute and Hospital.
Trial summary
In recent years, the development of lung cancer has been improved from pathological level to the molecular level. Research showed that there are many gene mutations in non-small cell lung cancer (NSCLC), and some activating mutations have become the hotspots in target therapy area. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- NSCLC
- How many people
- 513 participants
- Where
- No sites listed yet
- Study dates
- 27 Sep 2016to 1 Feb 2018
- Phase
- Observational
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: From May 2009 to November 2012, diagnosed lung cancer patients at Tianjin Medical University Cancer Institute \& Hospital were enrolled
Who may be able to join
- Patients enrolled from 2009 to 2012. Histological confirmed NSCLC.
Who cannot join
- Received any systemic or local treatment before surgery. Along with other malignant tumors. Lack up intact follow-up information.
About this study
Official title: Tianjin Medical University Cancer Institute and Hospital
In recent years, the development of lung cancer has been improved from pathological level to the molecular level. Research showed that there are many gene mutations in non-small cell lung cancer (NSCLC), and some activating mutations have become the hotspots in target therapy area. With the development of targeted drug research, the molecular classification of NSCLC will be more and more important. But a large number of clinical data showed that gene mutation in Chinese NSCLC patients is significantly different from Caucasian population, which suggesting that it is necessary to identify gene mutation profile in Chinese patients with NSCLC.
Six hundred NSCLC paraffin tissue samples was collected during operation from Tianjin Cancer hospital in 2009-2012, which including lung squamous cell carcinoma and adenocarcinoma. The target area of 295 genes, including lung cancer drive genes, important signal pathway genes, drug resistance genes will be detected by next-generation sequencing deep (average 1000X). We will identify gene mutation profile for Chinese lung squamous cell carcinoma and adenocarcinoma patients. The aim is to find related predictor and prognostic factors by analysing the relationship between these gene mutations and clinical characteristics and follow-up treatment.
Read the detailed description
The objective of this study is to build NSCLC gene mutation profile in China and find related correlation between gene mutation panel and clinical outcome.
Approximately 600 surgical tissue samples will be collected during operation in Tianjin Cancer hospital from 2009-2012, including lung squamous cell carcinoma and adenocarcinoma. The target area of 295 genes, including lung cancer drive genes, important signal pathway genes, drug resistance genes will be detected by New generation Sequencing (NGS) deep (average 1000X). This genes was selected from Mutations can guide treatment or as prognosis factors in NCCN/FDA/CFDA guideline, related mutations in phase II/III studies and NCCN/FDA/CFDA approved in other type tumors and related mutations in phase I or pre-clinical studies and can not guide treatment or as prognosis factors.
All mutations detected in 600 samples are summarized for statistics, calculating the mutation proportion in overall population. Clustering analysis is performed according to the main drive genes related biological pathways, correlation between gene mutation data and categorical clinical variables is performed by Fisher's Exact Test. The Log-rank test will be used to explore the relationship between the clinical outcomes (DFS and OS, respectively) and gene mutations (present or absent) or each of the clinical features (gender, age, smoking status, TNM staging, histology, tumor location, recurrence, number of lymph node metastasis, tumor size, postoperative adjuvant treatment, DFS and OS). Then a Cox Proportional Hazards model will be constructed to evaluate the effect of multiple variables (genomic and clinical features) on DFS, and OS, respectively. Benjamini-Hochberg false discovery rate (FDR) method is used to adjust the p-value and calculate the statistically differences. All p values were two-sided, and P<0.05 was assumed to be significant.
- Conditions
- NSCLC
- Keywords
- Chinese NSCLC, next-generation sequencing
What is being measured
The primary outcome is the main question the study is designed to answer.
The correlation between gene mutations and survival
The Log-rank test will be used to explore the relationship between the clinical outcomes (DFS and OS, respectively) and gene mutations (present or absent) or each of the clinical features (gender, age, smoking status, TNM staging, histology, tumor location, recurrence, number of lymph node metastasis, tumor size, postoperative adjuvant treatment, DFS and OS). Then a Cox Proportional Hazards model will be constructed to evaluate the effect of multiple variables (genomic and clinical features) on DFS, and OS, respectively. Benjamini-Hochberg false discovery rate (FDR) method is used to adjust the p-value and calculate the statistically differences. All p values were two-sided, and P<0.05 was assumed to be significant.
Measured: December 2017
Secondary outcomes (1)
The correlation between gene mutations and clinical parameters.
Correlation between gene mutation data and categorical clinical variables is performed by Fisher's Exact Test.
Measured: December 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2018
- Study start27 Sep 2016
- Primary completion27 Sep 2017
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 513 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca, Guangzhou Burning Rock Dx Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Changli Wang, Prof., Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03609918
- Sponsor's protocol ID
- E2016060A
- Status last verified
- Sep 2016
- First submitted
- 23 May 2018
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tianjin Medical University Cancer Institute and Hospital
- ClinicalTrials.gov ID
- NCT03609918
- Acronym / sponsor ID
- E2016060A
- Conditions
- NSCLC
- Keywords
- Chinese NSCLC, next-generation sequencing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 513 participants (actual)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- AstraZeneca, Guangzhou Burning Rock Dx Co., Ltd.
- Study start
- 27 Sep 2016 (actual)
- Primary completion
- 27 Sep 2017 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 1 Aug 2018 (actual)
- 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.
In recent years, the development of lung cancer has been improved from pathological level to the molecular level. Research showed that there are many gene mutations in non-small cell lung cancer (NSCLC), and some activating mutations have become the hotspots in target therapy area. With the development of targeted drug research, the molecular classification of NSCLC will be more and more important. But a large number of clinical data showed that gene mutation in Chinese NSCLC patients is significantly different from Caucasian population, which suggesting that it is necessary to identify gene mutation profile in Chinese patients with NSCLC.
Six hundred NSCLC paraffin tissue samples was collected during operation from Tianjin Cancer hospital in 2009-2012, which including lung squamous cell carcinoma and adenocarcinoma. The target area of 295 genes, including lung cancer drive genes, important signal pathway genes, drug resistance genes will be detected by next-generation sequencing deep (average 1000X). We will identify gene mutation profile for Chinese lung squamous cell carcinoma and adenocarcinoma patients. The aim is to find related predictor and prognostic factors by analysing the relationship between these gene mutations and clinical characteristics and follow-up treatment.
Detailed description
The objective of this study is to build NSCLC gene mutation profile in China and find related correlation between gene mutation panel and clinical outcome.
Approximately 600 surgical tissue samples will be collected during operation in Tianjin Cancer hospital from 2009-2012, including lung squamous cell carcinoma and adenocarcinoma. The target area of 295 genes, including lung cancer drive genes, important signal pathway genes, drug resistance genes will be detected by New generation Sequencing (NGS) deep (average 1000X). This genes was selected from Mutations can guide treatment or as prognosis factors in NCCN/FDA/CFDA guideline, related mutations in phase II/III studies and NCCN/FDA/CFDA approved in other type tumors and related mutations in phase I or pre-clinical studies and can not guide treatment or as prognosis factors.
All mutations detected in 600 samples are summarized for statistics, calculating the mutation proportion in overall population. Clustering analysis is performed according to the main drive genes related biological pathways, correlation between gene mutation data and categorical clinical variables is performed by Fisher's Exact Test. The Log-rank test will be used to explore the relationship between the clinical outcomes (DFS and OS, respectively) and gene mutations (present or absent) or each of the clinical features (gender, age, smoking status, TNM staging, histology, tumor location, recurrence, number of lymph node metastasis, tumor size, postoperative adjuvant treatment, DFS and OS). Then a Cox Proportional Hazards model will be constructed to evaluate the effect of multiple variables (genomic and clinical features) on DFS, and OS, respectively. Benjamini-Hochberg false discovery rate (FDR) method is used to adjust the p-value and calculate the statistically differences. All p values were two-sided, and P<0.05 was assumed to be significant.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- From May 2009 to November 2012, diagnosed lung cancer patients at Tianjin Medical University Cancer Institute \& Hospital were enrolled
Key inclusion criteria (1 listed)
- Patients enrolled from 2009 to 2012. Histological confirmed NSCLC.
Key exclusion criteria (1 listed)
- Received any systemic or local treatment before surgery. Along with other malignant tumors. Lack up intact follow-up information.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The correlation between gene mutations and survival
Time frame: December 2017
The Log-rank test will be used to explore the relationship between the clinical outcomes (DFS and OS, respectively) and gene mutations (present or absent) or each of the clinical features (gender, age, smoking status, TNM staging, histology, tumor location, recurrence, number of lymph node metastasis, tumor size, postoperative adjuvant treatment, DFS and OS). Then a Cox Proportional Hazards model will be constructed to evaluate the effect of multiple variables (genomic and clinical features) on DFS, and OS, respectively. Benjamini-Hochberg false discovery rate (FDR) method is used to adjust the p-value and calculate the statistically differences. All p values were two-sided, and P<0.05 was assumed to be significant.
1 secondary outcome
The correlation between gene mutations and clinical parameters.
Time frame: December 2017
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 7 Aug 2018.
- Individual participant dataSharing planned: Undecided
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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.
Changli Wang, Prof. principal investigator
Tianjin Medical University Cancer Institute and Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of NSCLC, run by Tianjin Medical University Cancer Institute and Hospital.
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 1 inclusion and 1 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 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The correlation between gene mutations and survival (time frame: December 2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2018.