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

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ClinicalTrials.gov Identifier: NCT01360255
Recruitment Status : Unknown
Verified December 2011 by Dominik Bettinger, University Hospital Freiburg.
Recruitment status was:  Recruiting
First Posted : May 25, 2011
Last Update Posted : December 15, 2011
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease
Hepatocellular Carcinoma

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.


Study Design

Study Type : Observational
Estimated Enrollment : 80 participants
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)
Study Start Date : May 2010
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011
Groups and Cohorts

Group/Cohort
Patients treated with TACE
Patients treated with transarterial chemoembolisation (TACE) are included in this clinical trial


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. long-term survival (1-year, 3-year, 5-year) [ Time Frame: up to 5 years ]
  3. progression- free - time [ Time Frame: up to 5 years ]

Biospecimen Retention:   Samples Without DNA
measurement of tumor markers AFP, AFP-L3 and DCP in serum samples

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dominik Bettinger, investigator, University Hospital Freiburg
ClinicalTrials.gov Identifier: NCT01360255     History of Changes
Other Study ID Numbers: HCC2
DRKS00000812 ( Registry Identifier: German Clinical Trials Register )
First Posted: May 25, 2011    Key Record Dates
Last Update Posted: December 15, 2011
Last Verified: December 2011

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

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