Clinical trial NCT02778854: Liquid Biopsy for Detection of Driver Mutation in NSCLC
Official title: Liquid Biopsy for Detection of Driver Mutation in Diagnostic and Prognostic of NSCLC
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non Small Cell Lung Cancer
Keywords: NSCLC
liquid biopsy
driver mutation
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2016-05-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility 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.

Exclusion Criteria:

* patients who are refused to provide the informed consent from

Primary outcomes:
measure: 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
timeFrame: 6 months
Secondary outcomes:
measure: 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
timeFrame: 6 months
measure: changes of driver mutation in quality and quantity in the process of targeted treatment to predict the prognosis
timeFrame: 5 years
measure: Progress-free survival(PFS) in patients who have had driver mutation and received the molecular target therapy
timeFrame: 3 years
measure: Overall survival(OS) in patients who had driver mutation and received the molecular target therapy
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: department of respiratory department ,Chinese PLA general hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Liang-an Chen, MD,PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.