Viewing Study NCT00155896



Ignite Creation Date: 2024-05-05 @ 11:53 AM
Last Modification Date: 2024-10-26 @ 9:15 AM
Study NCT ID: NCT00155896
Status: UNKNOWN
Last Update Posted: 2005-09-12
First Post: 2005-09-09

Brief Title: Establishing the Incidences of BRCA1 and BRCA2 Mutation by Combining DHPLC and Direct Sequencing in Ovarian Cancer
Sponsor: National Taiwan University Hospital
Organization: National Taiwan University Hospital

Study Overview

Official Title: None
Status: UNKNOWN
Status Verified Date: 2002-09
Last Known Status: RECRUITING
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: Ovarian cancer is the first mortality rate of gynecologic malignancies The incidence of ovarian cancer increased in recent 10 years Ovarian cancer indeed is a disease that should be respected however there were only few of research work focusing on it in Taiwan

To study the mechanisms of carcinogenesis of ovarian cancer will help us understand this disease and develop new strategies of diagnosis and prevention for ovarian cancer in the future The present diagnostic methods of malignancy are clinical symptoms physical examination evaluation of tumor markers and instruments It is a important issue to diagnose cancer earlier to improve the survival of cancer patients By the development of biomedical science many genes have been identified to be related with the carcinogenesis If we can detect the possibility of genetic mutation earlier we may deal with the suspected areas of malignancy as soon as possible To our present knowledge carcinogenesis of ovarian cancer has strong correlation with some special genes such as BRCA1 and BRCA2 genes There is 1 out of 200 normal population with BRCA1 or BRCA2 gene mutation in the western countries The incidences of BRCA1 or BRCA2 gene mutation even increase to 30-50 in the population of familial ovarian cancer Women with BRCA1 gene mutation have 80 to get breast cancer before the age of 70 and 63 of them would get ovarian cancer before the age of 70 Women with BRCA2 gene mutation have 80 to get breast or ovarian cancer before the age of 70 It seems that the genetic diagnosis of BRCA1BRCA2 has its clinical practice The development of new instrument- denaturing high-performance liquid chromatography DHPLC is to use automated detection to find out the minute or single mutation of nucleotide It has been applied to the clinical service by utilizing DHPLC for the genetic diagnosis of BRCA1 and BRCA2 of breast cancer patients in the department of Genetic Medicine of our hospital It will become a most powerful tool to establish the database of BRCA1 or BRCA2 gene mutation of the ovarian cancer patients in Taiwan when we can use the technique of DHPLC combining with the direct DNA sequencing
Detailed Description: Malignancy is the first cause of death in Taiwan There are around 30000 people died due to malignancy every year Ovarian cancer is the first mortality rate of gynecologic malignancies The incidence of ovarian cancer increased in recent 10 years Ovarian cancer indeed is a disease that should be respected however there were only few of research work focusing on it in Taiwan

To study the mechanisms of carcinogenesis of ovarian cancer will help us understand this disease and develop new strategies of diagnosis and prevention for ovarian cancer in the future The present diagnostic methods of malignancy are clinical symptoms physical examination evaluation of tumor markers and instruments It is a important issue to diagnose cancer earlier to improve the survival of cancer patients By the development of biomedical science many genes have been identified to be related with the carcinogenesis If we can detect the possibility of genetic mutation earlier we may deal with the suspected areas of malignancy as soon as possible To our present knowledge carcinogenesis of ovarian cancer has strong correlation with some special genes such as BRCA1 and BRCA2 genes There is 1 out of 200 normal population with BRCA1 or BRCA2 gene mutation in the western countries The incidences of BRCA1 or BRCA2 gene mutation even increase to 30-50 in the population of familial ovarian cancer Women with BRCA1 gene mutation have 80 to get breast cancer before the age of 70 and 63 of them would get ovarian cancer before the age of 70 Women with BRCA2 gene mutation have 80 to get breast or ovarian cancer before the age of 70 It seems that the genetic diagnosis of BRCA1BRCA2 has its clinical practice The development of new instrument- denaturing high-performance liquid chromatography DHPLC is to use automated detection to find out the minute or single mutation of nucleotide It has been applied to the clinical service by utilizing DHPLC for the genetic diagnosis of BRCA1 and BRCA2 of breast cancer patients in the department of Genetic Medicine of our hospital It will become a most powerful tool to establish the database of BRCA1 or BRCA2 gene mutation of the ovarian cancer patients in Taiwan when we can use the technique of DHPLC combining with the direct DNA sequencing

So we propose this research project There are two main purposes in this project First we will utilize the new technique of DHPCL with direct DNA sequence to set up the database of BRCA1 and BRCA2 gene mutation of ovarian cancer patients in Taiwan We can screen out BRCA1 and BRCA2 gene mutation from high-risk group by this new technique And then we can provide these patients suitable genetic consulting and related treatment planning Second we would lie to set up the new technique of DHPLC combining with direct DNA sequencing in the genetic diagnosis of ovarian cancer patients for the future clinical service in our hospital

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