Non-small Cell Lung CancerNCT04266483
Cancer Genome Atlas of China:Lung Cancer
An observational study of Non-small Cell Lung Cancer, run by Xuanwu Hospital, Beijing at 34 sites in China.
Trial summary
Based on 2500 lung cancer tumor tissue samples from about 40 clinical centers in China, the molecular typing of lung cancer in China will be figured out by high throughput sequencing, which will provide the basis for the follow-up research and development of new drugs as well as the guidance of treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Non-small Cell Lung Cancer
- How many people
- 2,500 participants
- Where
- 34 sitesChina
- Study dates
- 8 Nov 2019to 8 Nov 2022
- How long will I take part?
- 3 Years
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with stage Ⅲ or Ⅳ non-small cell lung cancer who are to receive tyrosine kinase inhibitors or immune checkpoint inhibitors for the first-line or adjuvant treatment.
Who may be able to join
- Pathologically diagnosed advanced non-small cell lung cancer
- Stage Ⅲ or Ⅳ non-small cell lung cancer and should to receive tyrosine kinase inhibitors or immune checkpoint inhibitors for the first-line or adjuvant treatment
- Able to provide 10ml anticoagulant peripheral blood and tumor tissue which should meet at least one of the following requirements: fresh tissue samples (≥ 1cm, at least 2 pieces) obtained by operation (1 piece, soybean size) or needle biopsy, 2 pieces of bronchoscopic biopsy tissue, paraffin section (thickness of 4-8 μm, operation or biopsy samples, ≥ 10 pieces, unstained)
- Able to provide basic clinical and pathological data
- Must be willing to be followed up
Who cannot join
- Small cell lung cancer
- Stage I or II non-small cell lung cancer
- Be not able to provide enough peripheral blood or tumor tissue
- Incomplete basic clinical data
- Unwilling to be followed up
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
China34 sites, 7 recruiting
- Active, not recruiting
Affiliated Hospital of Hebei University
Baoding, Hebei, 071000
- Active, not recruiting
The Fourth Medical Center of PLA General Hospital
Beijing, 100037
- Active, not recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, 100050
- Recruiting
Xuanwu Hospital,Beijing
Beijing, 100050
Yi Zhang, M.D., 13141370703
- Recruiting
Air Force Specialized Medical Center
Beijing, 100142
Yi Liu, M.D.& Ph.D., 15611161089
- Active, not recruiting
Air Force Specialized Medical Center
Beijing, 100142
- Active, not recruiting
Peking University Cancer Hospital
Beijing, 100142
- Active, not recruiting
The Seventh Medical Center of PLA General Hospital
Beijing, 100700
- Active, not recruiting
Beijing Hospital
Beijing, 100730
- Recruiting
Chinese PLA General Hospital
Beijing, 100853
Xiangyang Chu, M.D., 13501222241
- Active, not recruiting
Chinese PLA General Hospital
Beijing, 100853
- Active, not recruiting
Beijing Chest Hospital, Capital Medical University
Beijing, 101149
- Active, not recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130021
- Recruiting
Sino-Japan Friendship Hospital, Jilin University
Changchun, Jilin, 130031
Yuansong Bai, M.D.& Ph.D., 13944082211
- Recruiting
The Third Hospital of Jilin University
Changchun, Jilin, 130031
Yue Wang, M.D. & Ph.D., 13500804352
- Active, not recruiting
The First Hospital Affiliated to Dalian Medical University
Dalian, Liaoning, 116011
- Active, not recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
- Active, not recruiting
Guangzhou Institute of Respiratory Health
Guangzhou, Guangdong, 510120
- Active, not recruiting
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
- Active, not recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine (Binjiang District)
Hangzhou, Zhejiang, 310052
- Active, not recruiting
The Second Affiliated Hospital of Zhejiang University School of Medcine (Headquarters)
Hangzhou, Zhejiang, 313009
- Active, not recruiting
The Second Hospital Affiliated to Harbin Medical University
Harbin, Heilongjiang, 100051
- Active, not recruiting
Cancer Hospital Affiliated to Harbin Medical University
Harbin, Heilongjiang, 150000
- Active, not recruiting
The Second Hospital Affiliated to Harbin Medical University
Harbin, Heilongjiang, 150001
- Recruiting
Qilu Hospital, Shandong University
Jinan, Shandong, 250012
Hui Tian, M.D. & Ph.D., 18560080016
- Recruiting
Shandong Provincial Hospital
Jinan, Shangdong, 250021
Zhongmin Peng, M.D. & Ph.D., 13605409578
- Active, not recruiting
Hwa Mei Hospital, University of Chinese Academy of Sciences
Ningbo, Zhejiang, 315010
- Active, not recruiting
Renji Hospital,Shanghai Jiaotong University School of Medicine
Shanghai, 200001
- Active, not recruiting
Lung Hospital Affiliated to Shanghai Tongji Medical University
Shanghai, 200433
- Active, not recruiting
General Hospital of the Northern Theater of Chinese PLA
Shenyang, Liaoning, 110000
- Active, not recruiting
The First Hospital Affiliated to China Medical University
Shenyang, Liaoning, 110001
- Active, not recruiting
Liaoning Cancer Hospital
Shenyang, Liaoning, 110042
- Active, not recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011
- Active, not recruiting
General Hospital of Tianjin Medical University
Tianjin, 300052
About this study
Based on 2500 lung cancer tumor tissue samples from about 40 clinical centers in China, the molecular typing of lung cancer in China will be figured out by high throughput sequencing, which will provide the basis for the follow-up research and development of new drugs as well as the guidance of treatment.
Read the detailed description
This project will establish a standardized procedure of lung cancer sample collection, transportation, storage, detection, bioinformatics analysis and result judgment, so as to draw up the gene map of advanced lung cancer in China, and provide an important basis for the research and development of new drugs and the guidance of treatment.
Firstly, 2500 cases of lung cancer tumor tissue samples will be collected according to the Inclusion Criteria.
Secondly，samples will be sequenced through high throughput sequencing by ChosenMed Technology (Beijing) Co., Ltd., according to the strict process. Panel sequencing of the samples will be carried out through Illumina platform. After targeting Panel sequencing, four types of mutations including point mutation, insertion deletion, gene fusion and copy number variation will be detected, and tumor mutation burden as well as microsatellite instability will be evaluated. Combined with the bioinformatics analysis and sequencing results of the samples, the gene map of lung cancer in China will be drawn up, and the specific multigene panel of lung cancer for the Chinese population will be established as the basis for the subsequent clinical screening of molecular markers related to targeting therapy, immunotherapy and prognosis.
Thirdly, patients will be followed up on the information related to treatment after sequencing. According to the genetic information of the patients, the curative effect and prognosis of the patients will be followed up every three to six months. The follow-up time includes at least the first treatment plan after the patients' detection, which may continue until the final survival time of the patients, and explore the molecular markers and combinations that can affect the curative effect and prognosis of patients with lung cancer.
Finally, the clinical data and specimen information of patients will be managed and analyzed by Excel. Multivariate Cox regression analysis will be used to explore the clinical, pathological and molecular markers that affect the prognosis and curative effect of lung cancer, and draw the survival curve with the statistically significant indicators so as to provide reliable statistical results for the following clinical guidance.
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Non-small Cell Lung Cancer, Next-generation sequencing, High-throughput sequencing, Gene
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive gene profiles
Concordance between specific gene profiles and treatment outcomes
Measured: Follow up at least three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start8 Nov 2019
- Primary completion8 Nov 2022 (estimated)
- Study completion8 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- ChosenMed Technology (Beijing) Co.,Ltd
- Responsible party
- Sponsor
- Investigators
- Xiuyi Zhi, M.D., Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266483
- Sponsor's protocol ID
- YCZYPT[2018]06-01
- Status last verified
- Jan 2020
- First submitted
- 10 Feb 2020
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Genome Atlas of China:Lung Cancer
- ClinicalTrials.gov ID
- NCT04266483
- Acronym / sponsor ID
- YCZYPT[2018]06-01
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Non-small Cell Lung Cancer, Next-generation sequencing, High-throughput sequencing, Gene
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- ChosenMed Technology (Beijing) Co.,Ltd
- Study start
- 8 Nov 2019 (actual)
- Primary completion
- 8 Nov 2022 (estimated)
- Study completion
- 8 Nov 2022 (estimated)
- First posted
- 12 Feb 2020 (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.
Based on 2500 lung cancer tumor tissue samples from about 40 clinical centers in China, the molecular typing of lung cancer in China will be figured out by high throughput sequencing, which will provide the basis for the follow-up research and development of new drugs as well as the guidance of treatment.
Detailed description
This project will establish a standardized procedure of lung cancer sample collection, transportation, storage, detection, bioinformatics analysis and result judgment, so as to draw up the gene map of advanced lung cancer in China, and provide an important basis for the research and development of new drugs and the guidance of treatment.
Firstly, 2500 cases of lung cancer tumor tissue samples will be collected according to the Inclusion Criteria.
Secondly，samples will be sequenced through high throughput sequencing by ChosenMed Technology (Beijing) Co., Ltd., according to the strict process. Panel sequencing of the samples will be carried out through Illumina platform. After targeting Panel sequencing, four types of mutations including point mutation, insertion deletion, gene fusion and copy number variation will be detected, and tumor mutation burden as well as microsatellite instability will be evaluated. Combined with the bioinformatics analysis and sequencing results of the samples, the gene map of lung cancer in China will be drawn up, and the specific multigene panel of lung cancer for the Chinese population will be established as the basis for the subsequent clinical screening of molecular markers related to targeting therapy, immunotherapy and prognosis.
Thirdly, patients will be followed up on the information related to treatment after sequencing. According to the genetic information of the patients, the curative effect and prognosis of the patients will be followed up every three to six months. The follow-up time includes at least the first treatment plan after the patients' detection, which may continue until the final survival time of the patients, and explore the molecular markers and combinations that can affect the curative effect and prognosis of patients with lung cancer.
Finally, the clinical data and specimen information of patients will be managed and analyzed by Excel. Multivariate Cox regression analysis will be used to explore the clinical, pathological and molecular markers that affect the prognosis and curative effect of lung cancer, and draw the survival curve with the statistically significant indicators so as to provide reliable statistical results for the following clinical guidance.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with stage Ⅲ or Ⅳ non-small cell lung cancer who are to receive tyrosine kinase inhibitors or immune checkpoint inhibitors for the first-line or adjuvant treatment.
Key inclusion criteria (5 listed)
- Pathologically diagnosed advanced non-small cell lung cancer
- Stage Ⅲ or Ⅳ non-small cell lung cancer and should to receive tyrosine kinase inhibitors or immune checkpoint inhibitors for the first-line or adjuvant treatment
- Able to provide 10ml anticoagulant peripheral blood and tumor tissue which should meet at least one of the following requirements: fresh tissue samples (≥ 1cm, at least 2 pieces) obtained by operation (1 piece, soybean size) or needle biopsy, 2 pieces of bronchoscopic biopsy tissue, paraffin section (thickness of 4-8 μm, operation or biopsy samples, ≥ 10 pieces, unstained)
- Able to provide basic clinical and pathological data
- Must be willing to be followed up
Key exclusion criteria (5 listed)
- Small cell lung cancer
- Stage I or II non-small cell lung cancer
- Be not able to provide enough peripheral blood or tumor tissue
- Incomplete basic clinical data
- Unwilling to be followed up
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
Predictive gene profiles
Time frame: Follow up at least three years
Concordance between specific gene profiles and treatment outcomes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- 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.
Xiuyi Zhi, M.D. principal investigator
Xuanwu Hospital, Beijing
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by Xuanwu Hospital, Beijing at 34 sites 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kun Qian, M.D. (13810663559, 13810663559@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive gene profiles (time frame: Follow up at least three years). 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 17 Feb 2020.