Trial document





This trial has been registered retrospectively.
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  DRKS00000812

Trial Description

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Title

AFP - L3% and DCP as tumor markers in patients with hepatocellular carcinoma (HCC) treated with transarterial chemoembolisation (TACE)

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

The Hepatcellular carcinoma (HCC) is one of the tumors which is seen more and more worldwide. Often treatment possibilities are limited and only palliative treatment such as a trabsarterial chemoembolisation (TACE) is possible. Therapeutic response is evaluated three months after TACE by imaging techniques (CT, MRI). In some HCC patients the tumor marker afp ( alpha-fetoprotein) is elevated, but not all patients show this elevation. in the last years new tumor markers such as AFP-L3 (subfraction of AFP) and des-y-carboxyprothrombin (DCP) have been examined. In this clinical trail the course of these markers are examined after TACE in order to receive hints if the patinet will be a therapeutic responder.

Furthermore we are interested in the quality of life after TACE. These patients receive a questionnaire with regard to the quality of life before and 3 months after TACE

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Brief Summary in Scientific Language

Patients with Hepatocellular carcinoma (HCC) treated with transarterial chemoembolisation are enrolled in this clinical trial. The aim of this trial is to evaluate the usefulness of the liver cancer markers AFP, AFP-L3%(subfraction of afp) and des-y- carboxyprothrombin ( DCP) after TACE therapy. Some authors could have shown that AFP-L3% is rising in small tumor nodules under 2 cm and so the markers which should decrease after TACE can give a hint for the therapeutic response after the intervention. So the important aim of this trial is to improve the early detection of tumor recurrence after TACE.
Furthermore the quality of life measured by the EORTC QLQ C30 before and after TACE is evaluated.

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Organizational Data

  •   DRKS00000812
  •   2011/05/03
  •   2011/05/09
  •   yes
  •   Approved
  •   153/10, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   NCT01360255  (Clinical Trials)
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Health Condition or Problem studied

  •   C22.0 -  Malignant neoplasm: Liver cell carcinoma
  •   [---]* -  [---]*
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Interventions/Observational Groups

  •   Patients with HCC who are treated with transarterial chemoembolisation are enrolled in this trial. Before TACE serum samples are taken in order to perform the measurement of AFP, AFP-L3% and DCP. One month and three months after TACE serum samples are taken again and the markers are measured. Three months after TACE MRT or CT imaging is performed to evaluate the therapeutic response.

    Before TACE and three months after TACE the quality of life using the EORTC- QLQ C30 questionnaire is measured and compared.
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   [---]*
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Primary Outcome

- evaluation of the course of the liver cancer markers AFP, AFP-L3% and DCP after transarterial chemoembolisation.
- markers are measured before TACE, 1 month and 3 months after TACE. 3 months after TACE a MRI or CT imaging is performed to evaluate the therapeutic response
- analysing the quality of life before and after TACE (3 months after TACE) using the EORTC- QLQ- C30.

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Secondary Outcome

- long-term survival ( 1-year, 3- year, 5-year- survival)
- progression- free – time

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2010/06/10
  •   80
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

- age between 18 and 80
- diagnosis of HCC according the AASLD criteria
- TACE is planned
- resection is impossible

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Exclusion Criteria

- liver tumor of unknown origin
- other liver tumors
- TACE is impossible

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Addresses

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    • UKL Freiburg, Med. Klinik II
    • Mr.  Dr.   Michael  Schultheiß 
    • Hugstetter Str. 55
    • 79100  Freiburg
    • Germany
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    • UKL Freiburg, Med. Klinik II
    • Mr.  Dr.  Michael  Schultheiss 
    • Hugstetter Str. 55
    • 79100  Freiburg
    • Germany
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    • UKL Freiburg, Med. Klinik II
    • Mr.  Dr.  Michael  Schultheiss 
    • Hugstetter Str. 55
    • 79100  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • UKL Freiburg, Med. Klinik II
    • Mr.  Dr.  Michael  Schultheiss 
    • Hugstetter Str. 55
    • 79100  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2011/09/30
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Trial Publications, Results and other Documents

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