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Sponsors and Collaborators: |
National Health Research Institutes, Taiwan Chang Gung Memorial Hospital |
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Information provided by: | National Health Research Institutes, Taiwan |
ClinicalTrials.gov Identifier: | NCT00262171 |
The purpose of this study is to establish the HNPCC related information in Taiwan, and to characterize relevant susceptibility genes related to colorectal cancer to provide better disease control for the high-risk people. To accomplish this objective, we will collect detailed information of the HNPCC patients and their families from the collaborative hospitals and relate the information to the risk of CRC in order to provide sound disease control system in Taiwan.
Condition |
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Hereditary Nonpolyposis Colorectal Cancer |
Study Type: | Observational |
Study Design: | Family-Based, Prospective |
Official Title: | Hereditary Nonpolyposis Colorectal Cancer in Taiwan-Related Genetic Study and Clinical Applications |
Estimated Enrollment: | 800 |
Study Start Date: | May 2002 |
HNPCC is an autosomal dominant disease that is clinically characterized by the development of colorectal cancer (CRC) at an early age (mean age 44 years old). Four genes have been known to be related to this hereditary disease. It shows an excess of synchronous and metachronous tumors as well as a preponderance of right-sided tumors (70%). Another feature has been seen among the families of the HNPCC patients is the occurrence of adenocarcinomas at other sites (particularly at the endometrial, ovary, stomach, pancreas, ureter, renal pelvis, and skin). Difficulties arise in distinguishing environmental factors and genetic predisposition for familial clustering of CRC. The discovery of HNPCC germline mutations has been momentous in that it enables a clear distinction between carriers and noncarriers for those who were previously assigned a 50% risk of germline mutation. The informed consent provided by patients is important for the process of familial study and the search for germline mutations, these will further provide information for education and counseling. HNPCC has been reported to be responsible for about 1% to 13% of all CRC. The frequency of HNPCC varies by geographical areas.
The true incidence of HNPCC in Taiwan area is unclear. From year 1995 to 2000, 50 out of 4500(1.1%) patients were HNPCC according to the Amsterdam I criteria. MMR gene databases are crucial to understand the relationship between genotype and phenotype. Kindred sharing the same mutations but living in different places will provide the information to assess the contribution of environmental factors to colorectal carcinogenesis. The related clinical and basic researches are thus important for understanding the mutation spectrum of MMR genes, interaction between oncogenes, tumor suppressor genes, and roles of genetic polymorphisms in modifying MMR genes in Taiwan.
Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
The HNPCC patients and their families from the collaborative hospitals and relate the information to the risk of CRC in order to provide sound disease control system in Taiwan
Inclusion Criteria:
Select unaffected individuals in the following priority order:
Exclusion Criteria:
Contact: Guan-Yi Hung, MS | 886-37-246166 ext 36145 | guan@nhri.org.tw |
Taiwan | |
Division of Biostatistics and Bioinformatics, National Health Research Institites | Recruiting |
Miaoli County, Taiwan, 350 | |
Contact: Guan-Yi Hung, MD 886-37-246166 ext 36145 guan@nhri.org.tw |
Study Director: | Chao Hsiung, PhD. | Division of Biostatistics and Bioinformatics, National Health Research Institites |
Study Director: | Rei-Ping Tang, PhD. | Colorectal Section, Chang Gung Memorial Hospital |
Study Director: | Ling-Ling Hsieh, PhD. | Department of Public Health, Chang Gung University |
Responsible Party: | Sponsor and all collarators ( Sponsor and all collarators ) |
Study ID Numbers: | EC9012005 |
Study First Received: | December 5, 2005 |
Last Updated: | August 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00262171 History of Changes |
Health Authority: | Taiwan: Department of Health |
Digestive System Neoplasms Metabolic Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Cancer, Hereditary Nonpolyposis, Type 1 |
Digestive System Diseases Neoplastic Syndromes, Hereditary Colorectal Neoplasms, Hereditary Nonpolyposis Genetic Diseases, Inborn Hereditary Nonpolyposis Colon Cancer Gastrointestinal Neoplasms Metabolic Disorder Colorectal Neoplasms |
Metabolic Diseases Digestive System Neoplasms Gastrointestinal Diseases DNA Repair-Deficiency Disorders Colonic Diseases Intestinal Diseases Rectal Diseases Intestinal Neoplasms |
Neoplasms Neoplasms by Site Digestive System Diseases Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn Colorectal Neoplasms, Hereditary Nonpolyposis Gastrointestinal Neoplasms Colorectal Neoplasms |