Cancer Genome Atlas of China:Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

Official title:

Cancer Genome Atlas of China:Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04266483
• Other study ID #: YCZYPT[2018]06-01
• Status: Recruiting
• Start date: November 8, 2019
• Est. completion date: November 8, 2022

Study information

• Verified date: January 2020
• Source: Xuanwu Hospital, Beijing
• Contact: Kun Qian, M.D.
• Phone: 13810663559
• Email: 13810663559[@]139.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: November 8, 2022
• Est. primary completion date: November 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Pathologically diagnosed advanced non-small cell lung cancer

2. Stage ? or ? 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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Locations

Country	Name	City	State
China	Affiliated Hospital of Hebei University	Baoding	Hebei
China	Air Force Specialized Medical Center	Beijing
China	Air Force Specialized Medical Center	Beijing
China	Beijing Chest Hospital, Capital Medical University	Beijing
China	Beijing Friendship Hospital, Capital Medical University	Beijing
China	Beijing Hospital	Beijing
China	Chinese PLA General Hospital	Beijing
China	Chinese PLA General Hospital	Beijing
China	Peking University Cancer Hospital	Beijing
China	The Fourth Medical Center of PLA General Hospital	Beijing
China	The Seventh Medical Center of PLA General Hospital	Beijing
China	Xuanwu Hospital,Beijing	Beijing
China	Sino-Japan Friendship Hospital, Jilin University	Changchun	Jilin
China	The First Hospital of Jilin University	Changchun	Jilin
China	The Third Hospital of Jilin University	Changchun	Jilin
China	The First Hospital Affiliated to Dalian Medical University	Dalian	Liaoning
China	Guangzhou Institute of Respiratory Health	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	The First Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The Second Affiliated Hospital of Zhejiang University School of Medcine (Headquarters)	Hangzhou	Zhejiang
China	The Second Affiliated Hospital of Zhejiang University School of Medicine (Binjiang District)	Hangzhou	Zhejiang
China	Cancer Hospital Affiliated to Harbin Medical University	Harbin	Heilongjiang
China	The Second Hospital Affiliated to Harbin Medical University	Harbin	Heilongjiang
China	The Second Hospital Affiliated to Harbin Medical University	Harbin	Heilongjiang
China	Qilu Hospital, Shandong University	Jinan	Shandong
China	Shandong Provincial Hospital	Jinan	Shangdong
China	Hwa Mei Hospital, University of Chinese Academy of Sciences	Ningbo	Zhejiang
China	Lung Hospital Affiliated to Shanghai Tongji Medical University	Shanghai
China	Renji Hospital,Shanghai Jiaotong University School of Medicine	Shanghai
China	General Hospital of the Northern Theater of Chinese PLA	Shenyang	Liaoning
China	Liaoning Cancer Hospital	Shenyang	Liaoning
China	The First Hospital Affiliated to China Medical University	Shenyang	Liaoning
China	The Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	General Hospital of Tianjin Medical University	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Xuanwu Hospital, Beijing	ChosenMed Technology (Beijing) Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive gene profiles	Concordance between specific gene profiles and treatment outcomes	Follow up at least three years