Clinical trial NCT01492127: Evaluation of Proteasome as a Marker of Hepatocellular Carcinoma in Cirrhotic Patients Following Curative Treatment
Official title: Evolution of Plasma Proteasome Levels Following Curative Treatment of Hepatocellular Carcinoma in Cirrhotic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Cirrhosis
Keywords: Hepatocellular carcinoma
cirrhosis
proteasome
alpha-fetoprotein
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2011-12-14
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.

Eligibility criteria: 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

Primary outcomes:
measure: Variation of plasma proteasome
timeFrame: 3 months afterwards
Secondary outcomes:
measure: Variation of plasma proteasome
timeFrame: 6, 9 and 12 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: UH Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Natalie Funakoshi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Henry L, Lavabre-Bertrand T, Vercambre L, Ramos J, Carillo S, Guiraud I, Pouderoux P, Bismuth M, Valats JC, Demattei C, Duny Y, Chaze I, Funakoshi N, Bureau JP, Daures JP, Blanc P. Plasma proteasome level is a reliable early marker of malignant transformation of liver cirrhosis. Gut. 2009 Jun;58(6):833-8. doi: 10.1136/gut.2008.157016. Epub 2009 Feb 6.