Ignite Creation Date:
2024-05-05 @ 11:34 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01361061
Status:
COMPLETED
Last Update Posted:
2018-10-11
First Post:
2011-05-16
Brief Title:
AFP - L3 and DCP as Screening Marker for a Hepatocellular Carcinoma in Patients With Cirrhosis of the Liver
Sponsor:
University Hospital Freiburg
Organization:
University Hospital Freiburg
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2011-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
The incidence of the hepatocellular carcinoma HCC is rising worldwide Usually it arises in patients with liver cirrhosis Thats 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DRKS00000811 | REGISTRY | German Clinical Trials Register | None |