NGS-based Large-panel in Targeted Drug Delivery and Immunotherapy of Lung Cancer

Study Overview
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Brief Summary
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Companion diagnosis by large-panel is in increasing acceptance and need during clinical cancer management. The purpose of this trial is to investigate the benefit of large-panel NGS analysis in companion diagnosis of advanced lung cancer patients and further optimize the parameters.

Detailed Description
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Fresh tumor tissues and matched blood cells will be analyzed by large-panel (Berryoncology, lnc.) for multiple molecular biomarkers including mutations with sensitivity/resistance to targeted therapies, tumor mutational burden (TMB), microsatellite instability (MSI) status, etc., Therapeutic approach and outcome will be followed-up to inspect the clinical benefit by large-panel analysis. In addition, selected samples will be analyzed by WES to assess the correctness of TMB estimated by large-panel.

Official Title
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A Prospective Study on Companion Diagnosis by NGS-based Large-panel in Targeted Drug Delivery and Immunotherapy of Lung Cancer

Conditions
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Lung Neoplasms

Intervention / Treatment
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* Other: The method of gene mutation detection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant aged 18 or above, and gender unrestricted Individual with pathologically diagnosed lung cancer Exclusion Criteria: Patients with concomitant other tumors Individual with severe cardiopulmonary insufficiency and hypoproteinemia Women who were pregnant and were during their lactation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: The method of gene mutation detection|All samples were detected by large-panel, whereas some of which were also detected by WES.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) | PFS refers to the time from initial treatment to the time of disease progression or death | through the whole study period, an average of 3 year | 
| Tumor Mutational Burden (TMB) | TMB is defined as the total number of detected somatic mutation counts in coding regions per million bases | halfway of the study, an average of 1.5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other biomarkers | The distribution and clinical application value of molecular biomarkers such as Neoantigen, MSI and LOH in Chinese lung cancer patients | halfway of the study, an average of 1.5 year | 
| Clonality | The tumor clonality in Chinese lung cancer patients | halfway of the study, an average of 1.5 year | 
| Overall survival (OS) | OS refers to the time from the patient entering into the group to the time of death | through the whole study period, an average of 3 year |