Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00172757
Status:
UNKNOWN
Last Update Posted:
2005-11-28
First Post:
2005-09-12
Brief Title:
Association of Colorectal Cancer With Nutrition Diet Obesity Diabetes Mellitus and Genetic Alterations in Taiwan
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Risk Factors of Colorectal Cancer in Taiwan-With Special Reference to the Association With Nutrition Diet Obesity Diabetes Mellitus and Genetic Alterations
Status:
UNKNOWN
Status Verified Date:
2003-01
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:
We will explore the genetic including APC k-ras p53 MSI etc and environmental including family history life style diet nutritional status DM serum IGF-I IGFBP-3 etc risk factors of colorectal tumorigenesis We will accrue approximately 1000 patients as experimental group The control group consists of 2000 individuals who were confirmed without colorectal cancer or polyps by colonoscopy We estimated the statistical power of this study will reach more than 90 In the second year we will explore the association between various environmental risk factors with the epigenetic changes of various oncogenes and tumor suppressor genes Firstly we will study the correlation between hypermethylation of promoter region of hMLH1 gene with various environmental factors Next we will explore the genetic polymorphisms of promoter of E-cadherin gene Recently it has been reported that the CA genetic polymorphism in the promoter region of E-cadherin gene in prostate cancer Since this phenomenon has not been reported in colorectal cancer it is mandatory for us to extend our research to the E-cadherin polymorphisms of colorectal cancer Moreover this project will focus on exploration of the association between the genetic polymorphisms of promoter of TS gene with chemosensitivity to 5-Fu-based therapy We speculated that the better prognosis in colorectal tumors with MSI is related to their expression of TS gene In summary the second year of this project will extend our accumulated experience in the study of genetic polymorphisms to further clarify the association between genetic polymorphisms of TS gene with the prognosis of colorectal cancers after chemotherapy We believe that this project will facilitate 1 the further clarification of colorectal cancer tumorigenesis 2 the establishment of domestic epidemiological data of colorectal cancer of Taiwan and 3 the improvement of the quality of clinical management of patients with colorectal cancer
Detailed Description:
This is a two-year hospital-based case control study In the fist year we will set up solid database of our laboratory regarding the molecular genetics of colorectal cancer We will explore the genetic including APC k-ras p53 MSI etc and environmental including family history life style diet nutritional status DM serum IGF-I IGFBP-3 etc risk factors of colorectal tumorigenesis During the whole 2-year period of this project we will accrue approximately 1000 patients as experimental group The control group consists of 2000 individuals who were confirmed without colorectal cancer or polyps by colonoscopy We estimated the statistical power of this study will reach more than 90 In the second year we will explore the association between various environmental risk factors with the epigenetic changes of various oncogenes and tumor suppressor genes It has been well known that epigenetic changes of various oncogene and tumor suppressor genes was related to the intrinsic and extrinsic environmental alterations Firstly we will study the correlation between hypermethylation of promoter region of hMLH1 gene with various environmental factors Next we will explore the genetic polymorphisms of promoter of E-cadherin gene It has been well known that E-cadherin plays a major role in the maintenance of cellular structure Recently it has been reported that the CA genetic polymorphism in the promoter region of E-cadherin gene in prostate cancer The experimental method was feasible in our laboratory Since this phenomenon has not been reported in colorectal cancer it is mandatory for us to extend our research to the E-cadherin polymorphisms of colorectal cancer Moreover this project will focus on exploration of the association between the genetic polymorphisms of promoter of TS gene with chemosensitivity to 5-Fu-based therapy Recent reports indicated that colorectal tumors with MSI have better prognosis Moreover some authors indicated that the genetic polymorphisms of TS genes was related to chemosensitivity Therefore we speculated that the better prognosis in colorectal tumors with MSI is related to their expression of TS gene In summary the second year of this project will extend our accumulated experience in the study of genetic polymorphisms to further clarify the association between genetic polymorphisms of TS gene with the prognosis of colorectal cancers after chemotherapy We believe that this project will facilitate 1 the further clarification of colorectal cancer tumorigenesis 2 the establishment of domestic epidemiological data of colorectal cancer of Taiwan and 3 the improvement of the quality of clinical management of patients with colorectal cancer
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