Liquid Biopsy for Detection of Driver Mutation in Diagnostic and Prognostic of NSCLC
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Non Small Cell Lung Cancer
- Sponsor
- Chinese PLA General Hospital
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- 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
- Last Updated
- 8 years ago
Overview
Brief Summary
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 .
Detailed Description
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.
Investigators
Chen Liang_An
MD,PHD
Chinese PLA General Hospital
Eligibility Criteria
Inclusion Criteria
- •patients newly diagnosed with NSCLC confirmed by tissue biopsy and going to receive the detection of gene mutation or patients have obtained drug-resistance after receiving molecular target therapy and plan to re-biopsy.
- •Age ≥ 18 years
- •newly diagnosed patients have not received TKI and chemotherapy
- •patients who are drug-resistant have not received next-generation TKI
Exclusion Criteria
- •patients who have more than one type of carcinoma
- •patients who reject to sign the informed consent from
- •Inclusion Criteria:
- •patients from cohort1 with sensitive driver mutation and plan to receive TKI therapy
- •patients will have regular follow-up in Chinese people liberation army general hospital every month.
- •Exclusion Criteria:
- •patients who are refused to provide the informed consent from
Outcomes
Primary Outcomes
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
Time Frame: 6 months
Secondary Outcomes
- Overall survival(OS) in patients who had driver mutation and received the molecular target therapy(5 years)
- 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(5 years)
- Progress-free survival(PFS) in patients who have had driver mutation and received the molecular target therapy(3 years)