AFP - L3% and DCP as Screening Marker for a Hepatocellular Carcinoma in Patients With Cirrhosis of the Liver
Condition: Liver Cirrhosis
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Liver Cirrhosis; Fibrosis
Study type: Observational

Summary: 
      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 screening for HCC in patients with liver cirrhosis is performed by ultrasound and
      measurement of alpha- fetoprotein (AFP). In this trail the tumor markers AFP- L3 (a
      subfraction of AFP) and Des-y- carboxyprothromib (DCP) are measured in addition in order to
      receive information about the course of these markers before the detection of a HCC nodule.
    

Detailed description: 
      The incidence of the hepatocellular carcinoma (HCC) is rising worldwide. Usually it arises in
      patients with liver cirrhosis. That's the reason why these patients should be screened every
      six months by ultrasound performance and by the measurement of alpha-fetoprotein (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 Des-y- carboxyprothromib
      (DCP) and AFP - L3. AFP in total consists of three different glycoforms (AFP - L1, AFP - L2
      and AFP - L3) which all have a different binding affinity to the lens culinaris 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. Furthermore HCC
      - nodules with a diameter smaller than 2 cm could be detected by rising AFP - L3 serum
      levels. 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. In conclusion of that
      rising AFP - L3 serum levels could indicate a newly developed tumour.

      Des-y- carboxyprothromib (DCP), which was first described in 1984 by Liebmann et al. is
      another tumor marker for HCC. In contrast to AFP it is not elevated in patients with a benign
      disease of the liver. This could be an interesting fact concerning the screening of patients
      with liver cirrhosis.

      In this examination the diagnostic value of AFP, AFP - L3% and DCP should be evaluated. An
      important aim of this prospective clinical trial 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.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients approved cirrhosis of the liver, but without a HCC - suspected lesion, are
        included in this clinical trial
      
Biospecimen description: 
      measurement of tumor markers AFP, AFP-L3 and DCP in serum samples every 6 months
    
Keywords: liver cirrhosis; screening; hepatocellular carcinoma; liver cancer markers: AFP, AFP-L3% and DCP