AFP - L3% and DCP as Screening Marker for a Hepatocellular Carcinoma in Patients With Cirrhosis of the Liver

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2011 by University Hospital Freiburg
Sponsor:
Collaborators:
Wako Diagnostics
Johannes Gutenberg University Mainz
University Hospital Heidelberg
Information provided by (Responsible Party):
Dominik Bettinger, University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT01361061
First received: May 16, 2011
Last updated: December 14, 2011
Last verified: December 2011
  Purpose

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.


Condition
Liver Cirrhosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: AFP - L3% and DCP as Screening Marker for a Hepatocellular Carcinoma in Patients With Cirrhosis of the Liver- am Multicenter HCC- Surveillance Study

Resource links provided by NLM:


Further study details as provided by University Hospital Freiburg:

Primary Outcome Measures:
  • development of HCC [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
    all patients with liver cirrhosis in this clinical trial are examined every 6 months performing ultrasound and measurement of AFP, AFP-L3% and DCP


Secondary Outcome Measures:
  • comparison of these liver cancer markers (AFP, AFP-L3% and DCP) between men and women [ Time Frame: baseline ] [ Designated as safety issue: No ]
    The levels of these liver cancer markers are compared in men and women and it will be evaluated if one marker is superior than the others in men or women.

  • comparison of these liver cancer markers (AFP, AFP-L3% and DCP) between different etiologies [ Time Frame: baseline ] [ Designated as safety issue: No ]
    The levels of these liver cancer markers are compared between different etiologies and it will be evaluated if one marker is superior than the others in different causes of liver disease


Biospecimen Retention:   Samples Without DNA

measurement of tumor markers AFP, AFP-L3 and DCP in serum samples every 6 months


Estimated Enrollment: 600
Study Start Date: June 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
patients with liver cirrhosis

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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

Exclusion Criteria:

  • liver tumors or metastasis or tumor of unknown origin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01361061

Contacts
Contact: Hans Christian Spangenberg, Prof. Dr. (+49)761/270-34010 hans.spangenberg@uniklinik-freiburg.de
Contact: Dominik Bettinger (+49)761/270-34010 dominik.bettinger@uniklinik-freiburg.de

Locations
Germany
University Medical Center Freiburg Recruiting
Freiburg, Baden-Württemberg, Germany, 79106
Contact: Hans Christian Spangenberg, Prof. Dr.    (+49)0761/270-34010    hans.spangenberg@uniklinik-freiburg.de   
Contact: Dominik Bettinger    (+49)0761/270-34010    dominik.bettinger@uniklinik-freiburg.de   
Principal Investigator: Hans Christian Spangenberg, Prof. Dr.         
Sub-Investigator: Dominik Bettinger         
Sub-Investigator: Michael Schultheiß, Dr.         
University Medical Center Heidelberg Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Contact: Tom Ganten, PD Dr.    (+49)6221 - 560    tom.ganten@med.uni-heidelberg.de   
Principal Investigator: Tom Ganten, PD Dr.         
University Medical Center Mainz Recruiting
Mainz, Rheinland-Pfalz, Germany, 55131
Contact: Arndt Weinmann, Dr. MBA    (+49)6131 17-2669    weinmann@1-med.klinik.uni-mainz.de   
Principal Investigator: Arndt Weinmann, Dr.MBA         
Sponsors and Collaborators
University Hospital Freiburg
Wako Diagnostics
Johannes Gutenberg University Mainz
University Hospital Heidelberg
Investigators
Principal Investigator: Hans Christian Spangenberg, Prof. Dr. University Medical Center Freiburg
  More Information

No publications provided

Responsible Party: Dominik Bettinger, investigator, University Hospital Freiburg
ClinicalTrials.gov Identifier: NCT01361061     History of Changes
Other Study ID Numbers: HCC3, DRKS00000811
Study First Received: May 16, 2011
Last Updated: December 14, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Freiburg:
liver cirrhosis
screening
hepatocellular carcinoma
liver cancer markers: AFP, AFP-L3% and DCP

Additional relevant MeSH terms:
Carcinoma
Liver Cirrhosis
Fibrosis
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Diseases
Digestive System Diseases
Pathologic Processes
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on July 20, 2014