Liver CirrhosisNCT01361061
AFP - L3% and DCP as Screening Marker for a Hepatocellular Carcinoma in Patients With Cirrhosis of the Liver
An observational study of Liver Cirrhosis, run by University Hospital Freiburg at 2 sites in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cirrhosis
- How many people
- 450 participants
- Where
- 2 sitesGermany
- Study dates
- Jun 2010to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients approved cirrhosis of the liver, but without a HCC - suspected lesion, are included in this clinical trial
Who may be able to join
- 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
Who cannot join
- liver tumors or metastasis or tumor of unknown origin
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University Medical Center Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106
University Medical Center Mainz
Mainz, Rhineland-Palatinate, 55131
About this study
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
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.
Read the 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.
- Conditions
- Liver Cirrhosis
- Keywords
- liver cirrhosis, screening, hepatocellular carcinoma, liver cancer markers: AFP, AFP-L3% and DCP
- Medical subject headings
- Liver Cirrhosis, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with liver cirrhosis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
development of HCC
all patients with liver cirrhosis in this clinical trial are examined every 6 months performing ultrasound and measurement of AFP, AFP-L3% and DCP
Measured: up to 3 years
Secondary outcomes (2)
comparison of these liver cancer markers (AFP, AFP-L3% and DCP) between men and women
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.
Measured: baseline
comparison of these liver cancer markers (AFP, AFP-L3% and DCP) between different etiologies
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2011 (estimated)
- Study startJun 2010
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Collaborators
- Wako Diagnostics, Johannes Gutenberg University Mainz, University Hospital Heidelberg
- Responsible party
- Principal investigator, Dominik Bettinger, University Hospital Freiburg
- Investigators
- Hans Christian Spangenberg, Prof. Dr., Principal investigator, University Medical Center Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361061
- Sponsor's protocol ID
- HCC3
- Other IDs
- DRKS00000811
- Status last verified
- Dec 2011
- First submitted
- 16 May 2011
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01361061
- Acronym / sponsor ID
- HCC3
- Conditions
- Liver Cirrhosis
- Keywords
- liver cirrhosis, screening, hepatocellular carcinoma, liver cancer markers: AFP, AFP-L3% and DCP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Collaborators
- Wako Diagnostics, Johannes Gutenberg University Mainz, University Hospital Heidelberg
- Study start
- Jun 2010
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 26 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with liver cirrhosis | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients approved cirrhosis of the liver, but without a HCC - suspected lesion, are included in this clinical trial
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- liver tumors or metastasis or tumor of unknown origin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
development of HCC
Time frame: up to 3 years
all patients with liver cirrhosis in this clinical trial are examined every 6 months performing ultrasound and measurement of AFP, AFP-L3% and DCP
2 secondary outcomes
comparison of these liver cancer markers (AFP, AFP-L3% and DCP) between men and women
Time frame: baseline
comparison of these liver cancer markers (AFP, AFP-L3% and DCP) between different etiologies
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Christian Spangenberg, Prof. Dr. principal investigator
University Medical Center Freiburg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis, run by University Hospital Freiburg at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
development of HCC (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.