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Cancer Genome Atlas of China:Lung Cancer

Cancer Genome Atlas of China:Lung Cancer

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04266483
Enrollment
2500
Registered
2020-02-12
Start date
2019-11-08
Completion date
2022-11-08
Last updated
2020-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small Cell Lung Cancer, Next-generation sequencing, High-throughput sequencing, Gene

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.

Interventions

None listed

Sponsors

ChosenMed Technology (Beijing) Co.,Ltd
CollaboratorUNKNOWN
Xuanwu Hospital, Beijing
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Predictive gene profilesFollow up at least three yearsConcordance between specific gene profiles and treatment outcomes

Countries

China

Contacts

Primary ContactKun Qian, M.D.
13810663559@139.com13810663559

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026