Clinical Trial: Circulating Tumor Cells for Hepatocellular Carcinoma

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

Official Title: Circulating Tumor Cells (CTCs) as Biomarkers of Prognosis and Predictors of Efficacy of Drug Therapy for Patients With Hepatocellular Carcinoma

Brief Summary: To explore the clinical value of circulating tumor cells (CTCs) measurement for Hepatocellular carcinoma (HCC) patients.

Detailed Summary:

Background:The lack of tumor tissue for drug target and biomarker studies significantly limit the development of novel treatment for advanced HCC. In recent years, circulating tumor cells (CTCs) have been shown to be important prognostic biomarkers of overall survival for patients with breast, prostate, and colorectal cancer after anti-cancer therapy.

Methods and Materials:This project plans to enroll 50 HCC patients who receive curative surgery or radiofrequency ablation therapy, 50 patients who receive trans-arterial chemoembolization, and 50 patients who receive systemic therapy at National Taiwan University Hospital in 24 months for CTCs analysis. The eligible patients will receive blood tests before and after anti-cancer therapy. The blood samples will be separated to blood cells and plasma. Blood cells will be used for isolation and enumeration of CTCs. Plasma will be used to extract DNA to measure molecular aberration (gene mutations related to hepatocarcinogenesis or response of HCC cells to molecular targeted therapy)

  1. to explore the correlation between CTCs numbers and other clinical characteristics in HCC patients with different stages;
  2. to compare the patterns of molecular aberrations between CTC and HCC tumor tissue in HCC patients who have archival tumor tissue available; and
  3. to measure the changes of CTCs numbers and molecular aberrations in HCC patients before and after molecular targeted therapy.

Sponsor: National Taiwan University Hospital

Current Primary Outcome: Numbers of circulating tumor cells [ Time Frame: in 24 months ]

CTCs are measured by microfluidic disk platform. They are defined as tumor cells that are circulating in the peripheral blood of patients, which are shed from either the primary tumor or its metastases.


Original Primary Outcome: The correlation between circulating tumor cells numbers and survival time in HCC patients [ Time Frame: in 24 months ]

Current Secondary Outcome:

  • Overall survival [ Time Frame: 24 months ]
  • Clinical characteristics [ Time Frame: in 24 months ]

    The other clinical characteristics was defined as following characteristics:

    1. Sex
    2. Age
    3. Barcelona-Clinic Liver Cancer[BCLC] staging
    4. alpha feto protein[AFP] level
    5. Time to progression


Original Secondary Outcome:

  • The correlation between CTCs numbers and other clinical characteristics in HCC patients [ Time Frame: 24 months ]

    The other clinical characteristics was defined as following characteristics:

    1. Sex
    2. Age
    3. BCLC staging
    4. AFP level
    5. Time to progression
  • The comparison between CTCs numbers and molecular aberrations in HCC patients with molecular targeted therapy. [ Time Frame: in 24 months ]
    The comparison between CTCs numbers and molecular aberrations in HCC patients before and after molecular targeted therapy.


Information By: National Taiwan University Hospital

Dates:
Date Received: August 20, 2013
Date Started: October 2013
Date Completion:
Last Updated: November 13, 2013
Last Verified: November 2013