Viewing Study NCT01360255



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Last Modification Date: 2024-10-26 @ 10:35 AM
Study NCT ID: NCT01360255
Status: COMPLETED
Last Update Posted: 2018-10-11
First Post: 2011-05-09

Brief Title: AFP- L3 and DCP as Tumor Markers in Patients With Hepatocellular Carcinoma HCC Treated With Transarterial Chemoembolisation TACE
Sponsor: University Hospital Freiburg
Organization: University Hospital Freiburg

Study Overview

Official Title: AFP - L3 and DCP as Tumor Markers in Patients With Hepatocellular Carcinoma HCC Treated With Transarterial Chemoembolisation TACE
Status: COMPLETED
Status Verified Date: 2011-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
DRKS00000812 REGISTRY German Clinical Trials Register None