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Mutation Profile Detection, Therapeutic Resistance and Clonal Evolution Assessed With Liquid Biopsy of Advanced NSCLC Patients in China
To evaluate the concordance of sensitizing mutations detected between paired plasma and tissue samples; the correlation between the clonal status of sensitizing mutations and targeted therapy response; and the prognostic impact of the relative abundance of sensitizing / resistance mutations.
In the study, 500 advanced NSCLC patients will be recruited. All the patients will receive biopsy genotype assay and circultating tumor DNA (ctDNA) liquid biopsy. Patients who carry actionable EGFR mutation, ROS1 fusion, ALK fusion or MET exon 14 skipping mutation will receive TKI treatment according to guidelines. During the TKI treatment, every patients will take liquid biopsy assay to monitor the mutation status. The study will be ended when all the patients had a progressive disease (PD) in their targeted lesion.
Age
18 - 80 years
Sex
ALL
Healthy Volunteers
No
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
First Hospital of Jilin University
Changchun, China
Sir Run Run Shaw Hospital, Zhejiang University School of medicine
Hangzhou, China
The First Hospital of Zhejiang Province
Hangzhou, China
Anhui Provincial Hospital
Hefei, China
Jiangsu Jiangyin People's Hospital
Jiangyin, China
The Second Affiliated Hospital of Nanchang University
Nanchang, China
Ningbo No.2 Hospital
Ningbo, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
Shanghai Changzheng Hospital
Shanghai, China
Start Date
February 22, 2017
Primary Completion Date
December 31, 2019
Completion Date
January 30, 2020
Last Updated
February 5, 2020
300
ACTUAL participants
Lead Sponsor
Geneplus-Beijing Co. Ltd.
Collaborators
NCT07143110
NCT06885697
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04577599