Clinical trial NCT04266483: Cancer Genome Atlas of China:Lung Cancer
Official title: Cancer Genome Atlas of China:Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-small Cell Lung Cancer
Keywords: Non-small Cell Lung Cancer
Next-generation sequencing
High-throughput sequencing
Gene
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
Collaborators: name: ChosenMed Technology (Beijing) Co.,Ltd
First posted: 2020-02-12
Enrollment: 2500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Pathologically diagnosed advanced non-small cell lung cancer
2. 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
3. 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)
4. Able to provide basic clinical and pathological data
5. Must be willing to be followed up

Exclusion Criteria:

1. Small cell lung cancer
2. Stage I or II non-small cell lung cancer
3. Be not able to provide enough peripheral blood or tumor tissue
4. Incomplete basic clinical data
5. Unwilling to be followed up

Primary outcomes:
measure: Predictive gene profiles
timeFrame: Follow up at least three years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Institute of Respiratory Health
state: Guangdong
city: Baoding
country: China
facility: Affiliated Hospital of Hebei University
state: Hebei
city: Shijiazhuang
country: China
facility: The Fourth Hospital of Hebei Medical University
state: Hebei
city: Harbin
country: China
facility: The Second Hospital Affiliated to Harbin Medical University
state: Heilongjiang
city: Harbin
country: China
facility: Cancer Hospital Affiliated to Harbin Medical University
state: Heilongjiang
city: Harbin
country: China
facility: The Second Hospital Affiliated to Harbin Medical University
state: Heilongjiang
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Changchun
country: China
facility: Sino-Japan Friendship Hospital, Jilin University
state: Jilin
city: Changchun
country: China
facility: The Third Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: The First Hospital Affiliated to Dalian Medical University
state: Liaoning
city: Shenyang
country: China
facility: General Hospital of the Northern Theater of Chinese PLA
state: Liaoning
city: Shenyang
country: China
facility: The First Hospital Affiliated to China Medical University
state: Liaoning
city: Shenyang
country: China
facility: Liaoning Cancer Hospital
state: Liaoning
city: Jinan
country: China
facility: Qilu Hospital, Shandong University
state: Shandong
city: Jinan
country: China
facility: Shandong Provincial Hospital
state: Shangdong
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medicine (Binjiang District)
state: Zhejiang
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University School of Medcine (Headquarters)
state: Zhejiang
city: Ningbo
country: China
facility: Hwa Mei Hospital, University of Chinese Academy of Sciences
state: Zhejiang
city: Beijing
country: China
facility: The Fourth Medical Center of PLA General Hospital
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
city: Beijing
country: China
facility: Xuanwu Hospital,Beijing
city: Beijing
country: China
facility: Air Force Specialized Medical Center
city: Beijing
country: China
facility: Air Force Specialized Medical Center
city: Beijing
country: China
facility: Peking University Cancer Hospital
city: Beijing
country: China
facility: The Seventh Medical Center of PLA General Hospital
city: Beijing
country: China
facility: Beijing Hospital
city: Beijing
country: China
facility: Chinese PLA General Hospital
city: Beijing
country: China
facility: Chinese PLA General Hospital
city: Beijing
country: China
facility: Beijing Chest Hospital, Capital Medical University
city: Shanghai
country: China
facility: Renji Hospital,Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: Lung Hospital Affiliated to Shanghai Tongji Medical University
city: Tianjin
country: China
facility: General Hospital of Tianjin Medical University
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: Xiuyi Zhi, M.D.
role: PRINCIPAL_INVESTIGATOR
References: