AFP- L3% and DCP as Tumor Markers in Patients With Hepatocellular Carcinoma (HCC) Treated With Transarterial Chemoembolisation (TACE)
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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 |
|---|
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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) |
- 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
| 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 |
|---|
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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 |
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.
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| 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 | |
| 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. | |
| 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 Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases |
ClinicalTrials.gov processed this record on May 19, 2013