AFP – L3% and DCP as screening marker for a hepatocellular carcinoma in patients with cirrhosis of the liver

• Conditions: C22.0; K74.6; Liver cell carcinoma; Other and unspecified cirrhosis of liver

• Registration Number: DRKS00000811
• Lead Sponsor: KL Freiburg, Med. Klinik II

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-03
• Study Completion: 2015-01-16
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

age between 18 and 80
- cirrhosis of the liver confirmed by ultrasound or other imaging techniques (MRI, CT) or biopsy
- at the time of enrollment: no HCC- suspected lesion detectable in the liver

Exclusion Criteria

other liver tumors or metastasis or tumor of unknown origin

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- evaluation of the diagnostic usefulness of AFP, AFP-L3 and DCP alone and in combination (sensitivity, specifity)<br>- evaluation of the time of a positive tumor marker value in relation to the radiological detection of a tumor nodule (measurement of these markers every 6 months, ultrasound every 6 months)

Secondary Outcome Measures

Name	Time	Method
- differences in these tumor markers between men and women<br>- differences between etiologies