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
  Purpose

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.


Condition
Hepatocellular Carcinoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: AFP - L3% and DCP as Tumor Markers in Patients With Hepatocellular Carcinoma (HCC) Treated With Transarterial Chemoembolisation (TACE)

Resource links provided by NLM:


Further study details as provided by University Hospital Freiburg:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

measurement of tumor markers AFP, AFP-L3 and DCP in serum samples


Estimated Enrollment: 80
Study Start Date: May 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients treated with TACE
Patients treated with transarterial chemoembolisation (TACE) are included in this clinical trial

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01360255

Contacts
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

Locations
Germany
University Medical Center Freiburg Recruiting
Freiburg, Baden-Württemberg, Germany, 79106
Contact: Hans Christian Spangenberg, Prof. Dr.    (+49)0761/270-34010    hans.spangenberg@uniklinik-freiburg.de   
Contact: Dominik Bettinger    (+49)0761/270-34010    dominik.bettinger@uniklinik-freiburg.de   
Principal Investigator: Hans Christian Spangenberg, Prof. Dr.         
Sub-Investigator: Dominik Bettinger         
Sub-Investigator: Michael Schultheiß, Dr.         
Sponsors and Collaborators
University Hospital Freiburg
Wako Diagnostics
Investigators
Principal Investigator: Hans Christian Spangenberg, Prof. Dr. University Medical Center Freiburg
  More Information

No publications provided

Responsible Party: Dominik Bettinger, investigator, University Hospital Freiburg
ClinicalTrials.gov Identifier: NCT01360255     History of Changes
Other Study ID Numbers: HCC2, DRKS00000812
Study First Received: May 9, 2011
Last Updated: December 14, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Freiburg:
Hepatocellular Carcinoma
transarterial chemoembolisation
liver cancer markers: AFP, AFP-L3% and DCP

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on October 29, 2014