AFP- L3% and DCP as Tumor Markers in Patients With Hepatocellular Carcinoma (HCC) Treated With Transarterial Chemoembolisation (TACE)
Recruitment status was Recruiting
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.
|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)|
- 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
- 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
|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)|
Patients treated with TACE
Patients treated with transarterial chemoembolisation (TACE) are included in this clinical trial
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01360255
|Contact: Hans Christian Spangenberg, Prof. Dr.||(+49)firstname.lastname@example.org|
|Contact: Dominik Bettinger||(+49)email@example.com|
|University Medical Center Freiburg||Recruiting|
|Freiburg, Baden-Württemberg, Germany, 79106|
|Contact: Hans Christian Spangenberg, Prof. Dr. (+49)0761/270-34010 firstname.lastname@example.org|
|Contact: Dominik Bettinger (+49)0761/270-34010 email@example.com|
|Principal Investigator: Hans Christian Spangenberg, Prof. Dr.|
|Sub-Investigator: Dominik Bettinger|
|Sub-Investigator: Michael Schultheiß, Dr.|
|Principal Investigator:||Hans Christian Spangenberg, Prof. Dr.||University Medical Center Freiburg|