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

NCT01360255 | Completed

• 2 other identifiers: HCC2DRKS00000812
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• comparison of liver cancer markers AFP, AFP-L3% and DCP before and after TACE

  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 Outcomes (3)

• comparison of quality of life before and after TACE

  baseline and 3 months

• long-term survival (1-year, 3-year, 5-year)

  up to 5 years

• progression- free - time

  up to 5 years

Study Arms (1)

Patients treated with TACE

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• age between 18 and 80
• diagnosis of HCC according the AASLD criteria
• TACE is planned
• resection is impossible

You may not qualify if:

• liver tumor of unknown origin
• other liver tumors
• TACE is impossible

Sponsors & Collaborators

• University Hospital Freiburg: lead
• Wako Diagnostics: collaborator

Study Sites (1)

University Medical Center Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

measurement of tumor markers AFP, AFP-L3 and DCP in serum samples

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Hans Christian Spangenberg, Prof. Dr.

  University Medical Center Freiburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: investigator

Study Record Dates

• First Submitted: May 9, 2011
• First Posted: May 25, 2011
• Study Start: May 1, 2010
• Primary Completion: November 1, 2015
• Study Completion: November 15, 2015
• Last Updated: October 11, 2018

Record last verified: 2011-12

Locations

DE (1)