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Pharmacogenomics IND EXEMPT SNP Clinical Study - Etoposide and Single Nucleotide Polymorphisms — Drugs-SNPs  

Small Cell Lung Cancer Clinical Trial

Official title:
Explore the Relationship Between Single Nucleotide Polymorphisms and Etoposide Response and Toxicity in Patients With Small Cell Lung Cancer.

Clinical Trial Summary

Explore the relationship between drug target topoisomerase II gene single nucleotide polymorphisms and Etoposide (VP-16) therapeutic-effects in patients with small cell lung cancer, based on Oxford precisely sequencing drug targets' genes. Explore the relationship between drug target CYP4503A4 gene single nucleotide polymorphisms and Etoposide (VP-16) side-effects in patients with small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.

Clinical Trial Description

The usual approach group, after lung tissue biopsy, 300 double blind random group separated SCLC patients currently used the Combined Chemotherapy on Etoposide Injection, it will try to look for the relationship between the ETOPOSIDE therapeutic efficacy and the Topoisomerase II SNP Genotyping, and the relationship between the ETOPOSIDE therapeutic safety and the CYP4503A4 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes. The study approach group, after lung tissue biopsy, 300 double blind random group separated SCLC patients currently used the Combined Chemotherapy on Etoposide Capsule, it will try to look for the relationship between the ETOPOSIDE therapeutic efficacy and the Topoisomerase II SNP Genotyping, and the relationship between the ETOPOSIDE therapeutic safety and the CYP4503A4 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes. - 1) Detect drug target whole gene precision sequence of everyone patient for all 600 recruited double blind SCLC patients. - 2) Mutually compare everyone patient drug target whole gene precision sequence for a total of 600 recruited double blind SCLC patients. - 3) Calculate drug target gene SNPs in all 600 recruited double blind SCLC patients. - 4) Correlate everyone patient drug target gene SNP to everyone patient drug efficacy. - 5) Correlate everyone patient drug target gene SNP to everyone patient drug safety. - 6) Mutually compare the usual approach group SNPs (300 double blind random group separated SCLC patients) with the study approach group SNPs (300 double blind random group separated SCLC patients). - 7) Confirm the relationship between drug target gene SNPs and drug efficacy. - 8) Confirm the relationship between drug target gene SNPs and drug safety. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01064466
Study type Interventional
Source Medicine Invention Design, Inc
Contact
Status Active, not recruiting
Phase Phase 2/Phase 3
Start date January 2017
Completion date December 28, 2024
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