Therapeutic ResistAnce and Clonal Evolution Assessed With Liquid Biopsy of NSCLC Patients in China
Mutation Profile Detection, Therapeutic Resistance and Clonal Evolution Assessed With Liquid Biopsy of Advanced NSCLC Patients in China
1 other identifier
observational
300
1 country
14
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2017
Typical duration for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2017
CompletedStudy Start
First participant enrolled
February 22, 2017
CompletedFirst Posted
Study publicly available on registry
February 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2020
CompletedFebruary 5, 2020
February 1, 2020
2.9 years
February 16, 2017
February 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The mutation pattern of untreated advanced NSCLC and evolution of ctDNA mutation profile during TKI treatment.
2 years
Secondary Outcomes (1)
The concordance of gene mutation pattern between liquid biopsy and tissue biopsy.
1 year
Eligibility Criteria
treatment naïve Stage IIIB or Stage IV NSCLC patients, adenocarcinoma or squamous cell carcinoma without smoking history
You may qualify if:
- Provision of informed consent
- Newly diagnosed and histological or cytological confirmed stage IIIB-IV lung adenocarcinoma or non-smoking squamous cell carcinoma patients according to the AJCC staging system. The stage IV lung cancer and brain metastasis can be diagnosed by imaging and enhanced CT respectively
- ECOG performance status 0-2 with expected more than 6 months of survival time
- Willingness to comply with required protocols and give permission to use the data for clinical research and products development
You may not qualify if:
- Patients have other primary cancers
- Patients have symptomatic brain metastasis, complications that are associated with brain metastasis or cognitive disorders
- Patients failed in either plasma or tissue sample QC
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Geneplus-Beijing Co. Ltd.lead
- Shanghai Chest Hospitalcollaborator
Study Sites (14)
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120, 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
Shanghai Chest Hospital
Shanghai, China
Shanghai East Hospital
Shanghai, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Affiliated Hospital, Jiangnan University
Wuxi, China
Related Publications (1)
Ai X, Cui J, Zhang J, Chen R, Lin W, Xie C, Liu A, Zhang J, Yang W, Hu X, Hu X, Zhao Q, Rao C, Zang YS, Ning R, Li P, Chang L, Yi X, Lu S. Clonal Architecture of EGFR Mutation Predicts the Efficacy of EGFR-Tyrosine Kinase Inhibitors in Advanced NSCLC: A Prospective Multicenter Study (NCT03059641). Clin Cancer Res. 2021 Feb 1;27(3):704-712. doi: 10.1158/1078-0432.CCR-20-3063. Epub 2020 Nov 13.
PMID: 33188140DERIVED
Biospecimen
whole blood (including plasma, white cells), tissue
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shun Lu, MD
Shanghai Chest Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2017
First Posted
February 23, 2017
Study Start
February 22, 2017
Primary Completion
December 31, 2019
Study Completion
January 30, 2020
Last Updated
February 5, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share