Liquid Biopsy for Detection of Driver Mutation in NSCLC

• Conditions: Non Small Cell Lung Cancer
• Interventions: Genetic: detection of driver mutation

• Registration Number: NCT02778854
• Lead Sponsor: Chinese PLA General Hospital

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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-05-10
• Study First Submitted QC: 2016-05-18
• Study First Posted: 2016-05-20
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-07
• Last Update Posted: 2018-03-08
• Primary Completion: 2018-12
• Study Completion: 2020-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cohort 1	detection of driver mutation	Participants are recruited for diagnostic test
cohort 2	detection of driver mutation	participants are recruited for follow-up

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

department of respiratory department ,Chinese PLA general hospital; 🇨🇳 Beijing, Beijing, China