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

October 10, 2018 updated by: Dominik Bettinger, University Hospital Freiburg

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

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 Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Freiburg, Baden-Württemberg, Germany, 79106
        • University Medical Center Freiburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, 1 month and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline and 3 months
long-term survival (1-year, 3-year, 5-year)
Time Frame: up to 5 years
up to 5 years
progression- free - time
Time Frame: up to 5 years
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Freiburg

Collaborators

Wako Diagnostics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 15, 2015

Study Registration Dates

First Submitted

May 9, 2011

First Submitted That Met QC Criteria

May 24, 2011

First Posted (Estimate)

May 25, 2011

Study Record Updates

Last Update Posted (Actual)

October 11, 2018

Last Update Submitted That Met QC Criteria

October 10, 2018

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCC2
  • DRKS00000812 (Registry Identifier: German Clinical Trials Register)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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