Cancer Genome Atlas of China:Lung Cancer

NCT ID: NCT04266483

Last Updated: 2020-02-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-08

Study Completion Date

2022-11-08

Brief Summary

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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

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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

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Non-small Cell Lung Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ChosenMed Technology (Beijing) Co.,Ltd

UNKNOWN

Sponsor Role collaborator

Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiuyi Zhi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Xuanwu Hospital, Beijing

Locations

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Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Site Status ACTIVE_NOT_RECRUITING

Guangzhou Institute of Respiratory Health

Guangzhou, Guangdong, China

Site Status ACTIVE_NOT_RECRUITING

Affiliated Hospital of Hebei University

Baoding, Hebei, China

Site Status ACTIVE_NOT_RECRUITING

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status ACTIVE_NOT_RECRUITING

The Second Hospital Affiliated to Harbin Medical University

Harbin, Heilongjiang, China

Site Status ACTIVE_NOT_RECRUITING

Cancer Hospital Affiliated to Harbin Medical University

Harbin, Heilongjiang, China

Site Status ACTIVE_NOT_RECRUITING

The Second Hospital Affiliated to Harbin Medical University

Harbin, Heilongjiang, China

Site Status ACTIVE_NOT_RECRUITING

The First Hospital of Jilin University

Changchun, Jilin, China

Site Status ACTIVE_NOT_RECRUITING

Sino-Japan Friendship Hospital, Jilin University

Changchun, Jilin, China

Site Status RECRUITING

The Third Hospital of Jilin University

Changchun, Jilin, China

Site Status RECRUITING

The First Hospital Affiliated to Dalian Medical University

Dalian, Liaoning, China

Site Status ACTIVE_NOT_RECRUITING

General Hospital of the Northern Theater of Chinese PLA

Shenyang, Liaoning, China

Site Status ACTIVE_NOT_RECRUITING

The First Hospital Affiliated to China Medical University

Shenyang, Liaoning, China

Site Status ACTIVE_NOT_RECRUITING

Liaoning Cancer Hospital

Shenyang, Liaoning, China

Site Status ACTIVE_NOT_RECRUITING

Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Shandong Provincial Hospital

Jinan, Shangdong, China

Site Status RECRUITING

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status ACTIVE_NOT_RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medicine (Binjiang District)

Hangzhou, Zhejiang, China

Site Status ACTIVE_NOT_RECRUITING

The Second Affiliated Hospital of Zhejiang University School of Medcine (Headquarters)

Hangzhou, Zhejiang, China

Site Status ACTIVE_NOT_RECRUITING

Hwa Mei Hospital, University of Chinese Academy of Sciences

Ningbo, Zhejiang, China

Site Status ACTIVE_NOT_RECRUITING

The Fourth Medical Center of PLA General Hospital

Beijing, , China

Site Status ACTIVE_NOT_RECRUITING

Beijing Friendship Hospital, Capital Medical University

Beijing, , China

Site Status ACTIVE_NOT_RECRUITING

Xuanwu Hospital,Beijing

Beijing, , China

Site Status RECRUITING

Air Force Specialized Medical Center

Beijing, , China

Site Status RECRUITING

Air Force Specialized Medical Center

Beijing, , China

Site Status ACTIVE_NOT_RECRUITING

Peking University Cancer Hospital

Beijing, , China

Site Status ACTIVE_NOT_RECRUITING

The Seventh Medical Center of PLA General Hospital

Beijing, , China

Site Status ACTIVE_NOT_RECRUITING

Beijing Hospital

Beijing, , China

Site Status ACTIVE_NOT_RECRUITING

Chinese PLA General Hospital

Beijing, , China

Site Status RECRUITING

Chinese PLA General Hospital

Beijing, , China

Site Status ACTIVE_NOT_RECRUITING

Beijing Chest Hospital, Capital Medical University

Beijing, , China

Site Status ACTIVE_NOT_RECRUITING

Renji Hospital,Shanghai Jiaotong University School of Medicine

Shanghai, , China

Site Status ACTIVE_NOT_RECRUITING

Lung Hospital Affiliated to Shanghai Tongji Medical University

Shanghai, , China

Site Status ACTIVE_NOT_RECRUITING

General Hospital of Tianjin Medical University

Tianjin, , China

Site Status ACTIVE_NOT_RECRUITING

Countries

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China

Central Contacts

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Kun Qian, M.D.

Role: CONTACT

13810663559

Facility Contacts

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Yuansong Bai, M.D.& Ph.D.

Role: primary

13944082211

Yue Wang, M.D. & Ph.D.

Role: primary

13500804352

Hui Tian, M.D. & Ph.D.

Role: primary

18560080016

Zhongmin Peng, M.D. & Ph.D.

Role: primary

13605409578

Yi Zhang, M.D.

Role: primary

13141370703

Yi Liu, M.D.& Ph.D.

Role: primary

15611161089

Xiangyang Chu, M.D.

Role: primary

13501222241

Other Identifiers

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YCZYPT[2018]06-01

Identifier Type: -

Identifier Source: org_study_id

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