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

NCT01588860 | Unknown DMC

• 1 other identifier: 099084-F
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Biliary Tract Adenocarcinoma

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients diagnosed as biliary tact adenocarcinoma.

You may qualify if:

• The patients diagnosed as biliary tact adenocarcinoma.

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Department of Pathology, Far Eastern Memorial Hospital and National Taiwan University Hospital

Taipei, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fixed tissue in the paraffin embedded blocks

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2012
• First Posted: May 1, 2012
• Study Start: January 1, 2011
• Primary Completion: December 1, 2011
• Last Updated: May 1, 2012

Record last verified: 2010-12

Locations

TW (1)