Pharmacogenomics IND EXEMPT SNP Clinical Study - Etoposide and Single Nucleotide Polymorphisms
- Conditions
- Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT01064466
- Lead Sponsor
- Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 600
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ETOPOSIDE - Usual ETOPOSIDE - Usual * Etoposide Injection * Chemotherapy * Etoposide Injection * Usual Approach Group ETOPOSIDE - Study ETOPOSIDE - Study * Etoposide Capsule * Chemotherapy * Etoposide Capsule * Study Approach Group
- Primary Outcome Measures
Name Time Method Find Etoposide Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated. Duration at least 90 days 1. Recruit 300 double blind random group separated SCLC patients currently used the Combined Chemotherapy on Etoposide Injection after lung tissue biopsy, like as the usual approach group.
2. Recruit 300 double blind random group separated SCLC patients currently used the Combined Chemotherapy on Etoposide Capsule after lung tissue biopsy, like as the study approach group.
3. Assay above every SCLC patient-specific Etoposide (VP-16) drug target (Topoisomerase II) SNP genotype in his or her SCLC cell whole genome DNA with Oxford precisely sequencing.
4. Assay above every SCLC patient-specific Etoposide (VP-16) drug target (CYP4503A4) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Medicine Invention Design, Inc. (MIDI) - IORG0007849 - NPI 1023387701
🇺🇸Rockville, Maryland, United States