Trial document





This trial has been registered retrospectively.
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  DRKS00000811

Trial Description

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Title

AFP – L3% and DCP as screening marker for a hepatocellular carcinoma in patients with cirrhosis of the liver

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Trial Acronym

HCC - Surveillance- Trial

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URL of the Trial

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Brief Summary in Lay Language

Hepatocellular carcinoma (HCC) is one of the tumors with a rising incidence worldwide. The aim of this trial is to improve the detection of early HCC nodules in the liver. At the moment screnning for HCC in patients with cirrhosis of the liver is performed by ultrasound and measurment of alpha- fetoprotein (afp). In this trial the tumor markers AFP- L3 (subfraction of afp) and des-y- carboxyprothrombin (DCP) are measured in addition in order to receive information about the course of these markers before the detection of a HCC nodule.

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Brief Summary in Scientific Language

The incidence of the hepatocellular carcinoma (HCC) is rising worldwide. Usually it arises in patients with cirrhosis of the liver. That’s the reason why these patients should be screened every six months by ultrasound performance and by the measurement of AFP in order to detect a growing tumor in the cirrhotic liver so that a possible curative treatment may be possible.
In the last years new tumor markers has been identified such as DCP and AFP – L3. AFP in total consists of three different glykoforms (AFP – L1, AFP – L2 and AFP – L3) which all have a different binding affinity to the lens culinars agglutinin (LCA). Among these glycoproteins AFP – L3 has the highest binding affinity to LCA and occurs predominantly in patients with a HCC whereas the other subtypes can be found rather in patients with benign diseases of the liver such as a chronic hepatitis or cirrhosis of the liver.
Some studies have shown that high serum levels of AFP – L3 can be associated with a reduced function of the liver, low differentiation and a high malignancy of the HCC (Okuda et al.). Furthermore HCC – nodules with a diameter smaller than 2 cm could be detected by rising AFP – L3 serum levels (Dave Li et al.). Moreover there are significant differences in AFP – L3 serum levels in patients with cirrhosis of the liver without a HCC and those with such a tumor (Dökmeci et al.) In conclusion of that rising AFP – L3 serum levels could indicate a newly developed tumour.
DCP, which was first described in 1984 by Liebmann et al. is another tumor marker for the HCC. In contrast to AFP it does not elevated in patients with a benign disease of the liver. This could be an interesting fact concerning the screening of patients with cirrhosis of the liver.
In this examination the diagnostic value of AFP, AFP – L3% and DCP should be evaluated. An important aim of this study is to define the specificity of these serum markers alone and in combination. If a patient develops a primary liver tumor the course of the tumor markers before the development of the tumor will be analysed. Furthermore it will be examined which parameters will lead to false positive DCP values (especially chronic kidney disease or application of phenprocoumon). During 2 years approximately 150 patients in each center with approved cirrhosis of the liver will be enrolled. According to the normal screening procedure serum samples will be collected for the measurement of AFP, AFP- L3% and DCP. If a suspected tumor nodule is detected, a confirmation of the diagnosis “HCC” according to the AASLD- criteria is needed. These patients will be excluded from the examination and will be treated according to the actual guidelines.
The aim is to improve the early diagnosis of a HCC so that curative treatment opportunities can be done.



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Organizational Data

  •   DRKS00000811
  •   2011/05/03
  •   2011/05/16
  •   yes
  •   Approved
  •   154/10, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  •   NCT01361061  (Clinical Trials)
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Health Condition or Problem studied

  •   C22.0 -  Malignant neoplasm: Liver cell carcinoma
  •   K74.6 -  Other and unspecified cirrhosis of liver
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Interventions/Observational Groups

  •   During the regular screening for HCC nodules serum samples of patients with cirrhosis of the liver are taken in order to perform the measurement of AFP, AFP-L3 and DCP every 6 months. The duration of this trial will be 2 years.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Diagnostic
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

- evaluation of the diagnostic usefulness of AFP, AFP-L3 and DCP alone and in combination (sensitivity, specifity)
- evaluation of the time of a positive tumor marker value in relation to the radiological detection of a tumor nodule (measurement of these markers every 6 months, ultrasound every 6 months)

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Secondary Outcome

- differences in these tumor markers between men and women
- differences between etiologies

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2010/06/10
  •   600
  •   Multicenter 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
- cirrhosis of the liver confirmed by ultrasound or other imaging techniques (MRI, CT) or biopsy
- at the time of enrollment: no HCC- suspected lesion detectable in the liver

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Exclusion Criteria

other liver tumors or metastasis or tumor of unknown origin

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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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    • Universitätsklinikum Freiburg Medizinische Klinik II
    • Mr.  Dr.  Michael  Schultheiß 
    • Hugstetter Str. 55
    • 79106   Freiburg
    • Germany
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    • Wako Chemicals
    • Fuggerstr. 12
    • 41468   neuss
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/01/16
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.