Mutation Analysis and Copy Number Changes of KRAS and BRAF Gene in Taiwanese Cases of Biliary Tact Adenocarcinoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Far Eastern Memorial Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01588860
First received: April 27, 2012
Last updated: April 30, 2012
Last verified: December 2010
  Purpose

Cholangiocarcinoma is a fatal malignant neoplasm originating from biliary tracts and constitutes about 5-10% of primary liver cancers, characterized by a poor prognosis. High prevalence in southeast and eastern Asia has been observed. At present, the cellular and molecular mechanisms leading to oncogenesis of cholangiocarcinoma remain unclear.

The RAS gene product has a key role in controlling cell growth and differentiation through its intrinsic GTPase activity. Point mutations that activate the RAS protein and its downstream cascade have been observed in human tumors. Both KRAS and BRAF are members of the RAS-RAF-MEK-ERK-MAP kinase pathway which mediates cellular response to growth signals. Somatic KRAS mutations are found at high rates in leukemia, colon cancer, pancreatic cancer and lung cancer. Studies from European and Japanese groups have recently described that activating KRAS/ BRAF mutations may play a role in the carcinogenesis of cholangiocarcinoma of the biliary tracts, but our preliminary data demonstrated low frequency of KRAS and BRAF mutation in the same tumor as well as the results from Thailand. In this study, the investigators hypothesize copy number changes rather than genetic mutation of either KRAS or BRAF genes may be the key findings of Taiwanese cases of the adenocarcinoma from the biliary tracts.


Condition
Biliary Tract Adenocarcinoma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Mutation Analysis and Copy Number Changes of KRAS and BRAF Gene in Taiwanese Cases of Biliary Tact Adenocarcinoma

Resource links provided by NLM:


Further study details as provided by Far Eastern Memorial Hospital:

Biospecimen Retention:   Samples Without DNA

Fixed tissue in the paraffin embedded blocks


Estimated Enrollment: 100
Study Start Date: January 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
  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 patients diagnosed as biliary tact adenocarcinoma.

Criteria

Inclusion Criteria:

  • The patients diagnosed as biliary tact adenocarcinoma.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01588860

Locations
Taiwan
Department of Pathology, Far Eastern Memorial Hospital and National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
Far Eastern Memorial Hospital
  More Information

No publications provided

Responsible Party: Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT01588860     History of Changes
Other Study ID Numbers: 099084-F
Study First Received: April 27, 2012
Last Updated: April 30, 2012
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on July 22, 2014