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

University Hospital Center (CHU)

Status: Unknown

Conditions: Cirrhosis; Hepatocellular Carcinoma

Treatments: Biological: Blood test

Study type: Interventional

Funder types: Other

Identifiers

NCT01492127

UF 8671

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

64 participants in 1 patient group

Blood test

No Intervention group

Description:

Blood test :carcinoma in cirrhotic patients

Treatment:

Biological: Blood test