Liquid Biopsy for Detection of Driver Mutation in NSCLC

Non Small Cell Lung Cancer Clinical Trial

Official title:

Liquid Biopsy for Detection of Driver Mutation in Diagnostic and Prognostic of NSCLC

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02778854
• Other study ID #: S2015-099-01
• Status: Recruiting
• Phase: N/A
• First received: May 10, 2016
• Last updated: March 7, 2018
• Start date: October 2015
• Est. completion date: November 2020

Study information

• Verified date: March 2018
• Source: Chinese PLA General Hospital
• Contact: Liang-an Chen, MD,PHD
• Phone: 8610-55499027
• Email: cla301[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 2020
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non Small Cell Lung Cancer

Intervention

Genetic:
• detection of driver mutation
participants are received gene detection via the liquid biopsy

Locations

Country	Name	City	State
China	department of respiratory department ,Chinese PLA general hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	changes of driver mutation in quality and quantity in the process of targeted treatment to predict the prognosis		5 years
Secondary	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
Secondary	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