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Different Genetic Features Associated With Hepatic Carcinogenesis

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01247506
Collaborator
National Science Council, Taiwan (Other)
160
Enrollment
1
Location
28.9
Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to identify different genetic features in hepatocellular carcinoma. It will assist in predicting individual risks of disease progression and would help to clarify pathophysiological mechanisms of HCC.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Hepatocellular carcinoma (HCC) is a leading cause of cancer deaths in Taiwan. HCC normally develops as a consequence of underlying liver disease and is most often associated with cirrhosis. Surgical resection and liver transplantation are current best curative options to treat HCC. However, recurrence or metastasis is quite common in patients who have had a resection and survival rate is 30% to 40% at 5 years postoperatively.

    MicroRNAs, small non-coding RNA, act as endogenous RNA interference by post-transcription regulation. Recent studies suggest that microRNAs may act as tumor suppressors or oncogenes and altered microRNA expression levels may play an important role in the cancer initiation and progression. Several studies, including ourselves, have shown that specific microRNAs are aberrantly expressed in malignant HCC tissues compared to normal counterpart. Although many microRNA profiling studies were done to diagnose hepatocarcinogenesis, data about prognostic significances for postsurgical survival are very limited. The main point of this study is to develop a predictive signature for postsurgical survival in HCC patients.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    160 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Identification of Survival-related microRNAs in Hepatocellular Carcinoma
    Study Start Date :
    Feb 1, 2010
    Anticipated Primary Completion Date :
    Jul 1, 2012
    Anticipated Study Completion Date :
    Jul 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    1

    tumor tissues of HCC patients
    2

    paired nontumor tissues of HCC patients

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      45 Years to 70 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • clinical diagnosis of hepatocellular carcinoma
      Exclusion Criteria:

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 National Taiwan University Hospital Taipei Taiwan

      Sponsors and Collaborators

      • National Taiwan University Hospital
      • National Science Council, Taiwan

      Investigators

      • Study Chair: Po-Huang Lee, PhD, National Taiwan University Hospital

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT01247506
      Other Study ID Numbers:
      • 200912020R
      First Posted:
      Nov 24, 2010
      Last Update Posted:
      Nov 24, 2010
      Last Verified:
      Nov 1, 2010
      Keywords provided by , ,
      microRNA
      Additional relevant MeSH terms:
      Carcinoma
      Carcinoma, Hepatocellular

      Study Results

      No Results Posted as of Nov 24, 2010