Ignite Creation Date:
2024-05-06 @ 10:46 AM
Last Modification Date:
2024-10-26 @ 12:35 PM
Study NCT ID:
NCT03348670
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-16
First Post:
2017-11-15
Brief Title:
Pharmacogenomics IND EXEMPT SNP Clinical Study - Abiraterone and Single Nucleotide Polymorphisms
Sponsor:
Han Xu MD PhD FAPCR Sponsor-Investigator IRB Chair
Organization:
Medicine Invention Design Inc
Study Overview
Official Title:
Explore the Relationship Between Single Nucleotide Polymorphisms and Abiraterone Response and Toxicity in Patients With Prostate Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-10
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:
Drugs-SNPs
Brief Summary:
The usual approach group 300 double blind random group separated PC patients currently used the Combined Chemotherapy on ZYTIGA - abiraterone acetate tablet film coated plus RAYOS - prednisone tablet delayed release plus ORGOVYX - relugolix tablet film coated it will try to look for the relationship between the Abiraterone therapeutic efficacy and the CYP17 SNP Genotyping and the relationship between the Abiraterone therapeutic safety and the SULT2A1 SNP Genotyping based on Oxford precisely sequencing drug targets genes
The study approach group 300 double blind random group separated PC patients currently used the Combined Chemotherapy on ZYTIGA - abiraterone acetate tablet plus RAYOS - prednisone tablet delayed release plus ORGOVYX - relugolix tablet film coated it will try to look for the relationship between the Abiraterone therapeutic efficacy and the CYP17 SNP Genotyping and the relationship between the Abiraterone therapeutic safety and the SULT2A1 SNP Genotyping based on Oxford precisely sequencing drug targets genes
The study approach group 300 double blind random group separated PC patients currently used the Combined Chemotherapy on ZYTIGA - abiraterone acetate tablet plus RAYOS - prednisone tablet delayed release plus ORGOVYX - relugolix tablet film coated it will try to look for the relationship between the Abiraterone therapeutic efficacy and the CYP17 SNP Genotyping and the relationship between the Abiraterone therapeutic safety and the SULT2A1 SNP Genotyping based on Oxford precisely sequencing drug targets genes
Detailed Description:
1 Detect drug target whole gene precision sequence of everyone patient for all 600 recruited double blind prostate cancer patients
2 Mutually compare everyone patient drug target whole gene precision sequence for a total of 600 recruited double blind prostate cancer patients
3 Calculate drug target gene SNPs in all 600 recruited double blind prostate cancer 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 prostate cancer patients with the study approach group SNPs 300 double blind random group separated prostate cancer 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
2 Mutually compare everyone patient drug target whole gene precision sequence for a total of 600 recruited double blind prostate cancer patients
3 Calculate drug target gene SNPs in all 600 recruited double blind prostate cancer 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 prostate cancer patients with the study approach group SNPs 300 double blind random group separated prostate cancer 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| FWA00015357 | REGISTRY | None | None |
| IRB00009424 | REGISTRY | None | None |
| IORG0007849 | REGISTRY | None | None |
| NPI - 1831468511 | REGISTRY | None | None |
| NPI - 1023387701 | REGISTRY | None | None |
| IND 168800 | REGISTRY | FDA IND EXEMPT | None |