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

NCT ID: NCT01360255

Last Updated: 2018-10-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2015-11-15

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.

Conditions

Hepatocellular Carcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients treated with TACE

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

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wako Diagnostics

INDUSTRY

Sponsor Role: collaborator

University Hospital Freiburg

OTHER

Sponsor Role: lead

Responsible Party

Dominik Bettinger

investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hans Christian Spangenberg, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Freiburg

Locations

University Medical Center Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Countries

Germany

Other Identifiers

DRKS00000812

Identifier Type: REGISTRY

Identifier Source: secondary_id

HCC2

Identifier Type: -

Identifier Source: org_study_id