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 because the information has not been verified recently.
Verified December 2011 by University Hospital Freiburg.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Wako Diagnostics
Information provided by (Responsible Party):
Dominik Bettinger, University Hospital Freiburg
ClinicalTrials.gov Identifier:
NCT01360255
First received: May 9, 2011
Last updated: December 14, 2011
Last verified: December 2011

May 9, 2011
December 14, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • progression- free - time [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
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.
 
Recruiting
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
Both
18 Years to 80 Years
No
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
Germany
 
NCT01360255
HCC2, DRKS00000812
No
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP