Cancer Genome Atlas of China:Lung Cancer

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.

Study Overview

• Status: Unknown
• Conditions: Non-small Cell Lung Cancer

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 Type: Observational
• Enrollment (Anticipated): 2500

Contacts and Locations

• Study Contact: Name: Kun Qian, M.D.; Phone Number: 13810663559; Email: 13810663559@139.com

Study Locations

• China
  • Beijing, China, 100730
    • Active, not recruiting
    • Beijing Hospital
  • Beijing, China, 100853
    • Recruiting
    • Chinese PLA General Hospital
    • Contact: Xiangyang Chu, M.D.; Phone Number: 13501222241
  • Beijing, China, 100037
    • Active, not recruiting
    • The Fourth Medical Center of PLA General Hospital
  • Beijing, China, 100050
    • Active, not recruiting
    • Beijing Friendship Hospital, Capital Medical University
  • Beijing, China, 100050
    • Recruiting
    • Xuanwu Hospital,Beijing
    • Contact: Yi Zhang, M.D.; Phone Number: 13141370703
  • Beijing, China, 100142
    • Recruiting
    • Air Force Specialized Medical Center
    • Contact: Yi Liu, M.D.& Ph.D.; Phone Number: 15611161089
  • Beijing, China, 100142
    • Active, not recruiting
    • Air Force Specialized Medical Center
  • Beijing, China, 100142
    • Active, not recruiting
    • Peking University Cancer Hospital
  • Beijing, China, 100700
    • Active, not recruiting
    • the Seventh Medical Center of PLA General Hospital
  • Beijing, China, 100853
    • Active, not recruiting
    • Chinese PLA General Hospital
  • Beijing, China, 101149
    • Active, not recruiting
    • Beijing Chest Hospital, Capital Medical University
  • Shanghai, China, 200001
    • Active, not recruiting
    • Renji Hospital,Shanghai Jiaotong University School of Medicine
  • Shanghai, China, 200433
    • Active, not recruiting
    • Lung Hospital Affiliated to Shanghai Tongji Medical University
  • Tianjin, China, 300052
    • Active, not recruiting
    • General Hospital of Tianjin Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Active, not recruiting
      • Sun Yat-Sen University Cancer Center
    • Guangzhou, Guangdong, China, 510120
      • Active, not recruiting
      • Guangzhou Institute of Respiratory Health
  • Hebei
    • Baoding, Hebei, China, 071000
      • Active, not recruiting
      • Affiliated Hospital of Hebei University
    • Shijiazhuang, Hebei, China, 050011
      • Active, not recruiting
      • The Fourth Hospital of Hebei Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China, 100051
      • Active, not recruiting
      • The Second Hospital Affiliated to Harbin Medical University
    • Harbin, Heilongjiang, China, 150000
      • Active, not recruiting
      • Cancer Hospital Affiliated to Harbin Medical University
    • Harbin, Heilongjiang, China, 150001
      • Active, not recruiting
      • The Second Hospital Affiliated to Harbin Medical University
  • Jilin
    • Changchun, Jilin, China, 130021
      • Active, not recruiting
      • The First Hospital of Jilin University
    • Changchun, Jilin, China, 130031
      • Recruiting
      • Sino-Japan Friendship Hospital, Jilin University
      • Contact: Yuansong Bai, M.D.& Ph.D.; Phone Number: 13944082211
    • Changchun, Jilin, China, 130031
      • Recruiting
      • The Third Hospital of Jilin University
      • Contact: Yue Wang, M.D. & Ph.D.; Phone Number: 13500804352
  • Liaoning
    • Dalian, Liaoning, China, 116011
      • Active, not recruiting
      • The First Hospital affiliated to Dalian Medical University
    • Shenyang, Liaoning, China, 110000
      • Active, not recruiting
      • General Hospital of the Northern Theater of Chinese PLA
    • Shenyang, Liaoning, China, 110001
      • Active, not recruiting
      • The First Hospital Affiliated to China Medical University
    • Shenyang, Liaoning, China, 110042
      • Active, not recruiting
      • Liaoning cancer hospital
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Qilu Hospital, Shandong University
      • Contact: Hui Tian, M.D. & Ph.D.; Phone Number: 18560080016
  • Shangdong
    • Jinan, Shangdong, China, 250021
      • Recruiting
      • Shandong Provincial Hospital
      • Contact: Zhongmin Peng, M.D. & Ph.D.; Phone Number: 13605409578
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • Active, not recruiting
      • The First Affiliated Hospital of Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China, 310052
      • Active, not recruiting
      • The Second Affiliated Hospital of Zhejiang University School of Medicine (Binjiang District)
    • Hangzhou, Zhejiang, China, 313009
      • Active, not recruiting
      • The Second Affiliated Hospital of Zhejiang University School of Medcine (Headquarters)
    • Ningbo, Zhejiang, China, 315010
      • Active, not recruiting
      • Hwa Mei Hospital, University of Chinese Academy of Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive gene profiles	Concordance between specific gene profiles and treatment outcomes	Follow up at least three years

Collaborators and Investigators

• Sponsor: Xuanwu Hospital, Beijing
• Collaborators: ChosenMed Technology (Beijing) Co.,Ltd
• Investigators: Principal Investigator: Xiuyi Zhi, M.D., Xuanwu Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 8, 2019
• Primary Completion (ANTICIPATED): November 8, 2022
• Study Completion (ANTICIPATED): November 8, 2022

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 11, 2020
• First Posted (ACTUAL): February 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 17, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Non-small Cell Lung Cancer; Next-generation sequencing; Gene; High-throughput sequencing
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: YCZYPT[2018]06-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No