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Trial Title:
A Retrospective Study of EGFR-TKIs,Gefitinib, Erlotinib and Osimertinib in NSCLC Patients Treatment
NCT ID:
NCT01994057
Condition:
Non-small Cell Lung Cancer (NSCLC)
EGFR-TKI Resistant Mutation
EGFR-TKI Sensitizing Mutation
Germline Mutations
Somatic Mutation
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
Non-small cell lung cancer (NSCLC);
EGFR-TKI;
Pharmacogenetics;
Precision medicine
somatic mutations ,germline mutations;
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Summary:
For patients of advanced NSCLC (non small cell lung cancer) , Individualized cancer
therapy has been widely accepted since the success of crizotinib administration based on
EML4-ALK fusion gene detection and gefitinib and erlotinib administration based on
EGFR-TKIs sensitive mutations.From clinical points of view ,individual differences often
occur between different patients, leading diverse effect in ADR and drug effect.Meanwhile
,the drug effect and adverse drug reaction was significantly influenced by the
pharmacokinetic factors and pharmacodynamic factors.In this research ,we try to establish
a more sensitive method to detect sensitive mutations in plasma and discover the
correlation between somatic and germline mutations , trough concentration and EGFR-TKI
drug effect, the association between ADME-associated SNP ,trough concentration and
EGFR-TKI adverse effect .Furthermore, in vivo and in vitro research is also crucial for
rational explanation for these clinical phenomenon.
Detailed description:
The ADME-associated SNPs included are CYP3A4,CYP3A4,CYP1A1,CYP2D6, ABCB1,ABCG2 and so on
.The somatic mutations included are EGFR ,K-RAS ,ALK and so on
Criteria for eligibility:
Study pop:
locally advanced or metastatic NSCLC (non-small cell lung cancer) patients; administrated
with gefitinib,erlotinib .
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
The main patient entry criteria included: age≥ 18 years ; histologically and
cytologically proved NSCLC; Eastern cooperative oncology group performance status (ECOG
PS)≤2; adequate hematological , renal, and hepatic functions. Exclusion Criteria:
uncontrolled systemic disease ,any evidence of clinically active interstitial lung
diseases, and other chemotherapy at the time of inclusion. The protocol was approved by
the Ethical Committee of Cancer Center of Sun Yat-Sen University (CCSU), and written
informed consent was obtained form each patient.
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Center, Sun Yat-sen University
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Shuang Xin, PHD
Phone:
+86 13580479553
Email:
xshuang@mail2.sysu.edu.cn
Contact backup:
Last name:
shaoxing guan, PHD
Phone:
+86 13129351756
Phone ext:
13129351756
Email:
guanshx6@mail.sysu.edu.cn
Investigator:
Last name:
Min Huang, Professor
Email:
Principal Investigator
Start date:
September 2012
Completion date:
December 2026
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01994057
http://sps.sysu.edu.cn/
http://www.sysucc.org.cn/
