Non Small Cell Lung Cancer
Conditions
Keywords
NSCLC, liquid biopsy, driver mutation
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.
Interventions
GENETICdetection of driver mutation
participants are received gene detection via the liquid biopsy
Sponsors
Chinese PLA General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
cohort 1 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 cohort 2 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.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | compare the PFS between each participants via the change of driver mutation |
| Overall survival(OS) in patients who had driver mutation and received the molecular target therapy | 5 years | compare the OS between each participants via the change of driver mutation |
Countries
China
Contacts
Primary ContactLiang-an Chen, MD,PHD
Outcome results
None listed