- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00172757
Association of Colorectal Cancer With Nutrition, Diet, Obesity, Diabetes Mellitus, and Genetic Alterations in Taiwan
November 25, 2005 updated by: National Taiwan University Hospital
Risk Factors of Colorectal Cancer in Taiwan-With Special Reference to the Association With Nutrition, Diet, Obesity, Diabetes Mellitus, and Genetic Alterations
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 C→A 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.
Study Overview
Status
Unknown
Conditions
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 C→A 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 Type
Observational
Enrollment
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jin-Tung Liang, M.D., Ph.D.
- Phone Number: 886-2-23562068
- Email: jintung@ha.mc.ntu.edu.tw
Study Locations
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Taipei, Taiwan, 100
- Recruiting
- Department of Surgery, National Taiwan University Hospital, No.7, Chung-Shan South Road, Taipei, TAIWAN, R.O.C.
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Contact:
- Jin-Tung Liang, M.D., Ph.D.
- Phone Number: 886-2-23562068
- Email: jintung@ha.mc.ntu.edu.tw
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 second and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Consecutive cases of sporadic colorectal cancer in NTUH.
Exclusion Criteria:
- FAP and HNPCC.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2002
Study Completion
June 1, 2005
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Estimate)
November 28, 2005
Last Update Submitted That Met QC Criteria
November 25, 2005
Last Verified
January 1, 2003
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Diabetes Mellitus
- Colorectal Neoplasms
Other Study ID Numbers
- 9361701298
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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