Clinical trial NCT01360255: AFP- L3% and DCP as Tumor Markers in Patients With Hepatocellular Carcinoma (HCC) Treated With Transarterial Chemoembolisation (TACE)
Official title: AFP - L3% and DCP as Tumor Markers in Patients With Hepatocellular Carcinoma (HCC) Treated With Transarterial Chemoembolisation (TACE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular Carcinoma
transarterial chemoembolisation
liver cancer markers: AFP, AFP-L3% and DCP
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
Collaborators: name: Wako Diagnostics
First posted: 2011-05-25
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 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

Primary outcomes:
measure: comparison of liver cancer markers AFP, AFP-L3% and DCP before and after TACE
timeFrame: baseline, 1 month and 3 months
Secondary outcomes:
measure: comparison of quality of life before and after TACE
timeFrame: baseline and 3 months
measure: long-term survival (1-year, 3-year, 5-year)
timeFrame: up to 5 years
measure: progression- free - time
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: University Medical Center Freiburg
state: Baden-Württemberg
Study officials:
affiliation: University Medical Center Freiburg
name: Hans Christian Spangenberg, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: