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The purpose of this study is to evaluate the diagnostic and prognostic efficacy of liquid biopsy in different specimens and in different methods compared with tissue detection .
Collect plasma and other specimens from patients who are newly diagnosed with NSCLC or with drug-resistant and plan to receive gene detection to complete the diagnostic test for liquid biopsy .Participants who come from diagnostic test and plan to receive tyrosine kinase inhibitors (TKI) therapy will be collected plasma and other specimens every month during the regiments and monitor the changes of driver motion to predict the prognosis of targeted therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| cohort 1 | Participants are recruited for diagnostic test |
| |
| cohort 2 | participants are recruited for follow-up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| detection of driver mutation | Genetic | participants are received gene detection via the liquid biopsy |
|
| Measure | Description | Time Frame |
|---|---|---|
| concordance between tissue and plasma using detection method such as droplet digital PCR(ddPCR) or next generation sequencing(NGS) to detect the driver mutation in NSCLC | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| concordance between tissue and other specimens using detection method such as droplet digital PCR(ddPCR) or next generation sequencing(NGS) to detect the driver mutation in NSCLC | 6 months | |
| changes of driver mutation in quality and quantity in the process of targeted treatment to predict the prognosis |
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cohort 1
Inclusion Criteria:
Exclusion Criteria:
cohort 2
Inclusion Criteria:
Exclusion Criteria:
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patients who have been diagnosed with NSCLC and received detection of driver mutation in Chinese PLA general hospital
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liang-an Chen, MD,PHD | Contact | 8610-55499027 | cla301@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Liang-an Chen, MD,PHD | Chinese PLA General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| department of respiratory department ,Chinese PLA general hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30767431 | Derived | Wu Z, Yang Z, Li CS, Zhao W, Liang ZX, Dai Y, Zhu Q, Miao KL, Cui DH, Chen LA. Differences in the genomic profiles of cell-free DNA between plasma, sputum, urine, and tumor tissue in advanced NSCLC. Cancer Med. 2019 Mar;8(3):910-919. doi: 10.1002/cam4.1935. Epub 2019 Feb 14. |
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considering of personal privacy, the research-related individual participant data do not intend for public sharing.
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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body fluid
| 5 years |
| Progress-free survival(PFS) in patients who have had driver mutation and received the molecular target therapy | compare the PFS between each participants via the change of driver mutation | 3 years |
| Overall survival(OS) in patients who had driver mutation and received the molecular target therapy | compare the OS between each participants via the change of driver mutation | 5 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |