Evaluation of Proteasome as a Marker of Hepatocellular Carcinoma in Cirrhotic Patients Following Curative Treatment

Not Applicable

• Conditions: Hepatocellular Carcinoma; Cirrhosis
• Interventions: Biological: Blood test

• Registration Number: NCT01492127
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

This study will evaluate the usefulness of plasma proteasome levels as a tumor marker of hepatocellular carcinoma (HCC) by studying their variation following curative treatment of HCC. The hypothesis of the study is that plasma proteasome levels will decrease following curative treatment, and that proteasome levels could be used as a marker to detect early recurrence.

Detailed Description

HCC occurs in the vast majority of cases in the context of cirrhosis. Cirrhosis is considered a pre-cancerous state, which justifies systematic screening for HCC. Screening currently relies on measurement of alpha-foetoprotein (AFP) levels and ultrasound scans every 4 to 6 months. However, AFP has poor sensitivity as a marker for HCC. We have recently shown that plasma proteasome levels have a higher sensitivity than HCC for detecting HCC in cirrhotic patients, particularly when the tumors are small and can still benefit from curative treatment. The hypothesis of the study is that plasma proteasome levels will decrease following curative treatment, and that proteasome levels could be used as a marker to detect early recurrence. The goal of this study is to determine whether plasma proteasome levels in cirrhotic patients with HCC decrease following curative treatment (radiofrequency, surgical resection, liver transplantation). Plasma proteasome levels will be measured before treatment and 3 months after treatment, then subsequently at 3 month intervals over one year following treatment. The variation of proteasome levels will be compared to AFP levels. The sensitivity of proteasome as a marker to detect tumor recurrence will be evaluated, and compared to AFP.

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-12
• Study First Submitted QC: 2011-12-13
• Study First Posted: 2011-12-14
• Status Verified: 2013-04
• Primary Completion: 2014-03
• Last Update Submitted: 2015-04-22
• Last Update Posted: 2015-04-23
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Cirrhotic patients with hepatocellular carcinoma proven by histological examination of a biopsy specimen, eligible for curative treatment (radiofrequency, surgical resection, liver transplantation)
• Patient able to give informed consent
• Patient with Social Security coverage

Exclusion Criteria

• Secondary liver tumors
• Non hepatocellular carcinoma primary liver tumor
• Hepatocellular carcinoma without cirrhosis
• Patients with hepatocellular carcinoma and cirrhosis not eligible for curative treatment
• Prisoners
• Adults under guardianship or curatorship
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood test	Blood test	Blood test :carcinoma in cirrhotic patients

Primary Outcome Measures

Name	Time	Method
Variation of plasma proteasome	3 months afterwards	Variation of plasma proteasome levels before curative treatment of HCC and 3 months afterwards

Secondary Outcome Measures

Name	Time	Method
Variation of plasma proteasome	6, 9 and 12 months	Variation of plasma proteasome levels 6, 9 and 12 months following curative treatment for HCC, comparison with AFP levels and results from imaging studies

Trial Locations

Locations (1)

UH Montpellier; 🇫🇷 Montpellier, France