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

NCT ID: NCT01492127

Last Updated: 2015-04-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2016-03-31

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.

Conditions

Hepatocellular Carcinoma; Cirrhosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Blood test

Blood test :carcinoma in cirrhotic patients

Group Type: NO_INTERVENTION

Blood test

Intervention Type: BIOLOGICAL

Blood test

Interventions

Blood test

Blood test

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Natalie Funakoshi

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

UH Montpellier

Montpellier, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 19201777 (View on PubMed)

Other Identifiers

UF 8671

Identifier Type: -

Identifier Source: org_study_id