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

Sponsor
Far Eastern Memorial Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01588860
Collaborator
(none)
100
Enrollment
1
Location

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    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
    Study Start Date :
    Jan 1, 2011
    Actual Primary Completion Date :
    Dec 1, 2011

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      20 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • The patients diagnosed as biliary tact adenocarcinoma.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Department of Pathology, Far Eastern Memorial Hospital and National Taiwan University Hospital Taipei Taiwan

      Sponsors and Collaborators

      • Far Eastern Memorial Hospital

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Far Eastern Memorial Hospital
      ClinicalTrials.gov Identifier:
      NCT01588860
      Other Study ID Numbers:
      • 099084-F
      First Posted:
      May 1, 2012
      Last Update Posted:
      May 1, 2012
      Last Verified:
      Dec 1, 2010
      Additional relevant MeSH terms:
      Adenocarcinoma

      Study Results

      No Results Posted as of May 1, 2012