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Evolution of Plasma Proteasome Levels Following Curative Treatment of Hepatocellular Carcinoma in Cirrhotic Patients

18 Years
Open (Enrolling)
Hepatocellular Carcinoma, Cirrhosis

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Trial Information

Evolution of Plasma Proteasome Levels Following Curative Treatment of Hepatocellular Carcinoma in Cirrhotic Patients

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.

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

- Prisoners

- Adults under guardianship or curatorship

- Pregnancy

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Variation of plasma proteasome

Outcome Description:

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

Outcome Time Frame:

3 months afterwards

Safety Issue:


Principal Investigator

Natalie Funakoshi

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital, Montpellier


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

UF 8671



Start Date:

December 2011

Completion Date:

March 2015

Related Keywords:

  • Hepatocellular Carcinoma
  • Cirrhosis
  • Hepatocellular carcinoma
  • cirrhosis
  • proteasome
  • alpha-fetoprotein
  • Carcinoma
  • Liver Cirrhosis
  • Fibrosis
  • Carcinoma, Hepatocellular