AFP - L3% and DCP as Screening Marker for a Hepatocellular Carcinoma in Patients With Cirrhosis of the Liver
2 other identifiers
observational
450
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2010
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 16, 2011
CompletedFirst Posted
Study publicly available on registry
May 26, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedOctober 11, 2018
December 1, 2011
5.4 years
May 16, 2011
October 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
up to 3 years
Secondary Outcomes (2)
comparison of these liver cancer markers (AFP, AFP-L3% and DCP) between men and women
baseline
comparison of these liver cancer markers (AFP, AFP-L3% and DCP) between different etiologies
baseline
Study Arms (1)
patients with liver cirrhosis
Eligibility Criteria
All patients approved cirrhosis of the liver, but without a HCC - suspected lesion, are included in this clinical trial
You may qualify if:
- 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
You may not qualify if:
- liver tumors or metastasis or tumor of unknown origin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Freiburglead
- Wako Diagnosticscollaborator
- Johannes Gutenberg University Mainzcollaborator
- University Hospital Heidelbergcollaborator
Study Sites (2)
University Medical Center Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
University Medical Center Mainz
Mainz, Rhineland-Palatinate, 55131, Germany
Biospecimen
measurement of tumor markers AFP, AFP-L3 and DCP in serum samples every 6 months
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hans Christian Spangenberg, Prof. Dr.
University Medical Center Freiburg
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- investigator
Study Record Dates
First Submitted
May 16, 2011
First Posted
May 26, 2011
Study Start
June 1, 2010
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
October 11, 2018
Record last verified: 2011-12