Overview

This trial is active, not recruiting.

Conditions hepatocellular carcinoma, cirrhosis
Treatment blood test
Sponsor University Hospital, Montpellier
Start date December 2011
End date March 2014
Trial size 64 participants
Trial identifier NCT01492127, UF 8671

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Arm
(No Intervention)
Blood test :carcinoma in cirrhotic patients
blood test
Blood test

Primary Outcomes

Measure
Variation of plasma proteasome
time frame: 3 months afterwards

Secondary Outcomes

Measure
Variation of plasma proteasome
time frame: 6, 9 and 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Evolution of Plasma Proteasome Levels Following Curative Treatment of Hepatocellular Carcinoma in Cirrhotic Patients
Principal investigator Natalie Funakoshi
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by University Hospital, Montpellier.