Germline USP36 Mutation Confers Resistance to EGFR-TKIs by Upregulating MLLT3 Expression in Patients with Non-Small Cell Lung Cancer.
Shaoxing Guan, Xi Chen, Yuru Wei...
https://pubmed.ncbi.nlm.nih.gov/38261467/Actively Recruiting
Led by Sun Yat-sen University · Updated on 2023-04-12
1000
Participants Needed
1
Research Sites
60 weeks
Total Duration
Researchers are studying advanced non-small cell lung cancer NSCLC patients to understand how individual genetic differences affect the response and side effects of treatments called EGFR-TKIs, including gefitinib, erlotinib, and osimertinib. This observational study aims to find better ways to detect sensitive mutations in plasma and explore the relationship between various genetic mutations, drug concentrations, and treatment effects. The research also includes lab studies to explain these clinical observations. The study evaluates patients who have received EGFR-TKIs and categorizes them as sensitive or resistant based on their response after one and three months of treatment. Sensitive patients show complete or partial response or stable disease, while resistant patients show progressive disease. Genetic variations in ADME-associated genes and somatic mutations like EGFR and K-RAS are analyzed to see how they relate to drug effect and adverse reactions. Participants health is assessed through clinical and laboratory evaluations, including performance status and organ function tests. Researchers measure progression-free survival and track objective responses and adverse events at one and three months. The study includes patients aged 18 to 85 with confirmed NSCLC and follows them retrospectively to better understand the influence of genetic factors on treatment outcomes.
CONDITIONS
A Retrospective Study of EGFR-TKIs,Gefitinib, Erlotinib and Osimertinib in NSCLC Patients Treatment
S
shaoxing guan, PHD
M
Min Huang, Professor
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Sun Yat-sen University
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of treatment and follow-up as per medical records
Participants who underwent EGFR-TKI treatment are observed to assess treatment effects and side effects through collection of genetic and metabolomic data.
Data collection based on retrospective medical records
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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https://pubmed.ncbi.nlm.nih.gov/35695863/Sun Yat-sen University
Lead Sponsor