Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00459251
Status:
COMPLETED
Last Update Posted:
2007-04-11
First Post:
2007-04-10
Brief Title:
Pharmacogenetics Study in Taiwans Ethnic Groups
Sponsor:
Mackay Memorial Hospital
Organization:
Mackay Memorial Hospital
Study Overview
Official Title:
The Pharmacogenetics Study of Drug-Metabolising Enzyme Genetic Polymorphisms in Aboriginal and MinnanHakka Ethnic Groups in Taiwan
Status:
COMPLETED
Status Verified Date:
2007-04
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:
This main purpose of this study is to understand the difference and distribution of drug-metabolizing enzyme genetic polymorphisms among Taiwan ethnicities The subjects of study include Atayal Pawlan Yami Tsou Ami Minnan and Hakka We anticipate establishing a reference for the clinical medication in various ethnic groups according to the difference and distribution of the genetic polymorphisms
Detailed Description:
It has been shown that the same medication causes different responses in different individuals In addition to environments diets and physical conditions the genetic variations play an important role in the various responses For instant genetic variations in drug-metabolism enzymes may be responsible to different abilities in drug metabolism Some people have higher drug-metabolizing enzyme activity for certain drug and may need higher dose to reach the effective therapy some are poor in metabolizing the same drug and may cause adverse drug reactions Genetic variation also may cause different functions of the cell transporters The most notable example is that some tumor cells have a kind of transporters called p-glycoprotein which can pump out the anti-tumor drugs to extracellular and it turns the tumor cells become resistant to the drugs Hence if we can elucidate the gene variation of each individual we can give each individual different therapy based on their genetic variations This approach is called individualized medicine
In order to reach the goal of individualized medicine many studies have been focused on drug-metabolizing enzyme genetic variations between races or ethnicities Especially single nucleotide polymorphism provides a very important basis to clinical medication N- acetyltransferase 2 NAT2 is one kind of drug-metabolizing enzymes and its single nucleotide polymorphisms have remarkable effect on drug-metabolism Only 1030 are slow acetylators in Asian population but 4070 are found in Caucasian population Cytochrome P450 CYP450CYP is another important drug-metabolizing enzyme family Among the family the CYP2C9 CYP2C19 and CYP2D6 play key roles on drug metabolism Many literatures showed that all the three enzymes have various distributions of SNPs in different races It indicates that different races may have different abilities in drug-metabolizing enzymes Therefore it is important to provide a strategy to overcome the difficulties in individualized medicine
In the previous studies scientists often take Chinese as the representatives of Asian people and the Minnan Hakka or so-called Han people as the subjects when study the Taiwan ethnicity The genetic variations in the Taiwan aborigines are poorly investigated It has been showed that remarkable genetic variations in human leukocyte antigen HLA between Taiwan aborigines and Minnan Hakka by Lin ML and her colleagues They are highly homogenous within each tribe but diversified among the different tribes due to long-term isolation Therefore we expect to establish a database of genetic variations in drug-metabolism enzymes among these groups in order to use as the basis for clinical medication This study includes seven groups and each of them has 50 independent samples for drug-metabolizing enzyme genetic polymorphism analysis The important enzymes CYP2C9 CYP2C19 CYP2D6 and NAT2 etc are studied in this project ABI 7900HT instrument and traditional polymerase chain reaction PCR - restriction fragment length polymorphism RFLP both are used for SNPs analysis and gene sequence also would be used to confirm the results
In order to reach the goal of individualized medicine many studies have been focused on drug-metabolizing enzyme genetic variations between races or ethnicities Especially single nucleotide polymorphism provides a very important basis to clinical medication N- acetyltransferase 2 NAT2 is one kind of drug-metabolizing enzymes and its single nucleotide polymorphisms have remarkable effect on drug-metabolism Only 1030 are slow acetylators in Asian population but 4070 are found in Caucasian population Cytochrome P450 CYP450CYP is another important drug-metabolizing enzyme family Among the family the CYP2C9 CYP2C19 and CYP2D6 play key roles on drug metabolism Many literatures showed that all the three enzymes have various distributions of SNPs in different races It indicates that different races may have different abilities in drug-metabolizing enzymes Therefore it is important to provide a strategy to overcome the difficulties in individualized medicine
In the previous studies scientists often take Chinese as the representatives of Asian people and the Minnan Hakka or so-called Han people as the subjects when study the Taiwan ethnicity The genetic variations in the Taiwan aborigines are poorly investigated It has been showed that remarkable genetic variations in human leukocyte antigen HLA between Taiwan aborigines and Minnan Hakka by Lin ML and her colleagues They are highly homogenous within each tribe but diversified among the different tribes due to long-term isolation Therefore we expect to establish a database of genetic variations in drug-metabolism enzymes among these groups in order to use as the basis for clinical medication This study includes seven groups and each of them has 50 independent samples for drug-metabolizing enzyme genetic polymorphism analysis The important enzymes CYP2C9 CYP2C19 CYP2D6 and NAT2 etc are studied in this project ABI 7900HT instrument and traditional polymerase chain reaction PCR - restriction fragment length polymorphism RFLP both are used for SNPs analysis and gene sequence also would be used to confirm the results
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