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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by National Health Research Institutes, Taiwan.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Chang Gung Memorial Hospital
Information provided by:
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT00262171
First received: December 5, 2005
Last updated: August 12, 2009
Last verified: August 2009
  Purpose

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
Hereditary Nonpolyposis Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Family-Based
Time Perspective: Prospective
Official Title: Hereditary Nonpolyposis Colorectal Cancer in Taiwan-Related Genetic Study and Clinical Applications

Resource links provided by NLM:


Further study details as provided by National Health Research Institutes, Taiwan:

Estimated Enrollment: 800
Study Start Date: May 2002
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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:

  • N/A
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00262171

Contacts
Contact: Guan-Yi Hung, MS 886-37-246166 ext 36145 guan@nhri.org.tw

Locations
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   
Sponsors and Collaborators
National Health Research Institutes, Taiwan
Chang Gung Memorial Hospital
Investigators
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
  More Information

No publications provided

Responsible Party: Sponsor and all collarators
ClinicalTrials.gov Identifier: NCT00262171     History of Changes
Other Study ID Numbers: EC9012005
Study First Received: December 5, 2005
Last Updated: August 12, 2009
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Colorectal Neoplasms
Colorectal Neoplasms, Hereditary Nonpolyposis
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
DNA Repair-Deficiency Disorders
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Genetic Diseases, Inborn
Intestinal Diseases
Intestinal Neoplasms
Metabolic Diseases
Neoplasms
Neoplasms by Site
Neoplastic Syndromes, Hereditary
Rectal Diseases

ClinicalTrials.gov processed this record on October 23, 2014