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AFP- L3% and DCP as Tumor Markers in Patients With Hepatocellular Carcinoma (HCC) Treated With Transarterial Chemoembolisation (TACE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by Dominik Bettinger, University Hospital Freiburg.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01360255
First Posted: May 25, 2011
Last Update Posted: December 15, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Wako Diagnostics
Information provided by (Responsible Party):
Dominik Bettinger, University Hospital Freiburg
May 9, 2011
May 25, 2011
December 15, 2011
May 2010
December 2011   (Final data collection date for primary outcome measure)
comparison of liver cancer markers AFP, AFP-L3% and DCP before and after TACE [ Time Frame: baseline, 1 month and 3 months ]
Liver cancer markers AFP, AFP-L3 and DCP are measured before TACE, 1 month and 3 months after TACE in order to evaluate the course of these markers after the intervention
Same as current
Complete list of historical versions of study NCT01360255 on ClinicalTrials.gov Archive Site
  • comparison of quality of life before and after TACE [ Time Frame: baseline and 3 months ]
    analysing the quality of life before and after TACE (3 months after TACE) using the EORTC- QLQ- C30.
  • long-term survival (1-year, 3-year, 5-year) [ Time Frame: up to 5 years ]
  • progression- free - time [ Time Frame: up to 5 years ]
Same as current
Not Provided
Not Provided
 
AFP- L3% and DCP as Tumor Markers in Patients With Hepatocellular Carcinoma (HCC) Treated With Transarterial Chemoembolisation (TACE)
AFP - L3% and DCP as Tumor Markers in Patients With Hepatocellular Carcinoma (HCC) Treated With Transarterial Chemoembolisation (TACE)

Hepatocellular carcinoma (HCC) is one of the tumors with an increasing incidence worldwide. Often treatment possibilities are limited and only palliative treatment such as a transarterial chemoembolisation (TACE) is possible. Therapeutic response is evaluated three months after TACE by imaging techniques (CT, MRI). In some HCC patients the tumor marker AFP ( alpha-fetoprotein) is elevated, but not all patients show this elevation. In the last years new tumor markers such as AFP-L3 (subfraction of AFP) and des-y-carboxyprothrombin (DCP) have been examined. In this clinical trial the course of these markers are examined after TACE in order to receive hints if the patient will be a therapeutic responder.

Furthermore the investigators are interested in the quality of life after TACE. Patients receive a questionnaire with regard to the quality of life before and 3 months after TACE.

Patients with hepatocellular carcinoma (HCC) treated with transarterial chemoembolisation are enrolled in this clinical trial. The aim of this trial is to evaluate the usefulness of the liver cancer markers AFP, AFP-L3% (subfraction of AFP) and des-y- carboxyprothrombin (DCP) after TACE therapy. Some authors could have shown that AFP-L3% is rising in small tumor nodules under 2 cm and so the markers which should decrease after TACE can give a hint for the therapeutic response after the intervention. So the important aim of this trial is to improve the early detection of tumor recurrence after TACE.

Furthermore the quality of life measured by the EORTC QLQ C30 before and after TACE is evaluated.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:
measurement of tumor markers AFP, AFP-L3 and DCP in serum samples
Non-Probability Sample
Patients with confirmed hepatocellular carcinoma according to the AASLD criteria and who are treated with transarterial chemoembolisation (TACE) are included in this clinical trial. The patients are recruted in our primary care clinic in the department of gastroenterology and hepatology.
Hepatocellular Carcinoma
Not Provided
Patients treated with TACE
Patients treated with transarterial chemoembolisation (TACE) are included in this clinical trial
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
80
December 2011
December 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • age between 18 and 80
  • diagnosis of HCC according the AASLD criteria
  • TACE is planned
  • resection is impossible

Exclusion Criteria:

  • liver tumor of unknown origin
  • other liver tumors
  • TACE is impossible
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01360255
HCC2
DRKS00000812 ( Registry Identifier: German Clinical Trials Register )
No
Not Provided
Not Provided
Dominik Bettinger, University Hospital Freiburg
University Hospital Freiburg
Wako Diagnostics
Principal Investigator: Hans Christian Spangenberg, Prof. Dr. University Medical Center Freiburg
University Hospital Freiburg
December 2011