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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01360255

Enrollment

Registered

2011-05-25

Start date

2010-05-31

Completion date

2015-11-15

Last updated

2018-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma, transarterial chemoembolisation, liver cancer markers: AFP, AFP-L3% and DCP

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
comparison of liver cancer markers AFP, AFP-L3% and DCP before and after TACE	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

Secondary

Measure	Time frame	Description
comparison of quality of life before and after TACE	baseline and 3 months	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)	up to 5 years	—
progression- free - time	up to 5 years	—

Countries

Germany

Outcome results