Liquid Biopsy for Detection of Driver Mutation in NSCLC

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

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 .

Study Overview

• Status: Unknown
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Genetic: detection of driver mutation

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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Liang-an Chen, MD,PHD; Phone Number: 8610-55499027; Email: cla301@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Recruiting
      • department of respiratory department ,Chinese PLA general hospital
      • Contact: Liang-an Chen, MD,PHD; Phone Number: 8610-55499027; Email: cla301@126.com
      • Principal Investigator: Liang-an Chen, MD,PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients who have been diagnosed with NSCLC and received detection of driver mutation in Chinese PLA general hospital

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
cohort 1; Participants are recruited for diagnostic test	Genetic: detection of driver mutation; participants are received gene detection via the liquid biopsy
cohort 2; participants are recruited for follow-up	Genetic: detection of driver mutation; participants are received gene detection via the liquid biopsy

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	compare the PFS between each participants via the change of driver mutation	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	5 years

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Investigators: Principal Investigator: Liang-an Chen, MD,PHD, Chinese PLA General Hospital

Publications and helpful links

General Publications

• Wu Z, Yang Z, Li CS, Zhao W, Liang ZX, Dai Y, Zhu Q, Miao KL, Cui DH, Chen LA. Differences in the genomic profiles of cell-free DNA between plasma, sputum, urine, and tumor tissue in advanced NSCLC. Cancer Med. 2019 Mar;8(3):910-919. doi: 10.1002/cam4.1935. Epub 2019 Feb 14.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): November 1, 2020

Study Registration Dates

• First Submitted: May 10, 2016
• First Submitted That Met QC Criteria: May 18, 2016
• First Posted (Estimate): May 20, 2016

Study Record Updates

• Last Update Posted (Actual): March 8, 2018
• Last Update Submitted That Met QC Criteria: March 7, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: NSCLC; liquid biopsy; driver mutation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: S2015-099-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: considering of personal privacy, the research-related individual participant data do not intend for public sharing.