ClinicalTrials.gov
ClinicalTrials.gov Menu

Hereditary Nonpolyposis Colorectal Cancer in Taiwan-Related Genetic Study and Clinical Applications

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00262171
Recruitment Status : Unknown
Verified March 2016 by National Health Research Institutes, Taiwan.
Recruitment status was:  Active, not recruiting
First Posted : December 6, 2005
Last Update Posted : April 7, 2016
Sponsor:
Collaborator:
Chang Gung Memorial Hospital
Information provided by (Responsible Party):
National Health Research Institutes, Taiwan

December 5, 2005
December 6, 2005
April 7, 2016
May 2002
August 2016   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00262171 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Hereditary Nonpolyposis Colorectal Cancer in Taiwan-Related Genetic Study and Clinical Applications
Hereditary Nonpolyposis Colorectal Cancer in Taiwan-Related Genetic Study and Clinical Applications
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.
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.
Observational
Observational Model: Family-Based
Time Perspective: Prospective
Not Provided
Not Provided
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
Hereditary Nonpolyposis Colorectal Cancer
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
1014
800
August 2016
August 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Select all affected individuals. If the affected is unavailable, select the spouse and adult children (20+) of these unavailable affected individuals.
  • Select unaffected individuals in the following priority order:

    1. study both parents of the affected individuals;
    2. if parents are not available, study up to two siblings of each missing parent (if both parents are deceased, study four siblings - two from each parent);
    3. study up to five unaffected siblings (age 20 or older) of the affected individual; if more than five siblings are available for study, select the siblings from oldest to youngest;
    4. study up to three children (age 20 or older) of the affected individual; again, select the three oldest children if more than three are available;
    5. if the two affected individuals in the multiplex family are not siblings, (first cousins, for example, then study common grandparents - if common grandparents are not available, study siblings of these grandparents) when children of the affected individual's are studied, the child's unaffected parent will also be selected for study.

Exclusion Criteria:

Sexes Eligible for Study: All
20 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT00262171
EC9012005
No
Not Provided
Plan to Share IPD: Undecided
National Health Research Institutes, Taiwan
National Health Research Institutes, Taiwan
Chang Gung Memorial Hospital
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
National Health Research Institutes, Taiwan
March 2016