Liquid Biopsy for Detection of Driver Mutation in NSCLC

Chinese PLA General Hospital200 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Non Small Cell Lung Cancer

Interventions

detection of driver mutationGENETIC

participants are received gene detection via the liquid biopsy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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. Exclusion Criteria: * patients who are refused to provide the informed consent from

Locations (1)

department of respiratory department ,Chinese PLA general hospital

Beijing, Beijing Municipality, China

RECRUITING

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

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

Time frame: 6 months

changes of driver mutation in quality and quantity in the process of targeted treatment to predict the prognosis

Time frame: 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

Time frame: 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

Time frame: 5 years

Central Contacts

Liang-an Chen, MD,PHD

CONTACT

8610-55499027 cla301@126.com

Data from ClinicalTrials.gov

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