Ignite Creation Date:
2024-05-06 @ 2:12 AM
Last Modification Date:
2024-10-26 @ 11:15 AM
Study NCT ID:
NCT01994057
Status:
RECRUITING
Last Update Posted:
2023-04-12
First Post:
2013-11-01
Brief Title:
A Retrospective Study of EGFR-TKIsGefitinib Erlotinib and Osimertinib in NSCLC Patients Treatment
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
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-TKIsGefitinib and Erlotinib in Non-small Cell Lung Cancer Treatment
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 mutationsFrom clinical points of view individual differences often occur between different patients leading diverse effect in ADR and drug effectMeanwhile the drug effect and adverse drug reaction was significantly influenced by the pharmacokinetic factors and pharmacodynamic factorsIn 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 CYP3A4CYP3A4CYP1A1CYP2D6 ABCB1ABCG2 and so on The somatic mutations included are EGFR K-RAS ALK and so on
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2 | OTHER | China National Natural Science Foundation | None |