RecruitingRecruiting
A Retrospective Study of EGFR-TKIs,Gefitinib, Erlotinib and Osimertinib in NSCLC Patients Treatment
NCT01994057 · Sun Yat-sen University
In plain English
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Official title
Retrospective Study Based on Somatic Mutations, Genetic Polymorphisms and Metabolomics Related to Individual Variations of Drug Effect and Adverse Drug Reaction of EGFR-TKIs,Gefitinib and Erlotinib in Non-small Cell Lung Cancer Treatment.
About this study
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
Eligibility 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.
Study design
Enrollment target: 1000 participants
Age groups: adult, older_adult
Timeline
Starts: 2012-09
Estimated completion: 2026-12
Last updated: 2023-04-12
Primary outcomes
- • Progression free survival (The length of time from either the date of diagnosis to that patients diagnosed with the disease are still alive)
Sponsor
Sun Yat-sen University · other
Contacts & investigators
Contactshaoxing guan, PHD · contact · guanshx6@mail.sysu.edu.cn · +86 13129351756
ContactMin Huang, Professor · contact · huangmin@mail.sysu.edu.cn · +86 020 87331409-101
InvestigatorMin Huang, Professor · study_chair, school of pharmaceutical sciences , SunYat-senU
All locations (1)
Cancer Center, Sun Yat-sen UniversityRecruiting
Guangzhou, Guangdong, China