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

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ClinicalTrials.gov Identifier: NCT01492127
Recruitment Status : Unknown
Verified April 2013 by University Hospital, Montpellier.
Recruitment status was:  Active, not recruiting
First Posted : December 14, 2011
Last Update Posted : April 23, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Cirrhosis Biological: Blood test Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Evolution of Plasma Proteasome Levels Following Curative Treatment of Hepatocellular Carcinoma in Cirrhotic Patients
Study Start Date : December 2011
Actual Primary Completion Date : March 2014
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Blood test
Blood test :carcinoma in cirrhotic patients
Biological: Blood test
Blood test



Primary Outcome Measures :
  1. Variation of plasma proteasome [ Time Frame: 3 months afterwards ]
    Variation of plasma proteasome levels before curative treatment of HCC and 3 months afterwards


Secondary Outcome Measures :
  1. Variation of plasma proteasome [ Time Frame: 6, 9 and 12 months ]
    Variation of plasma proteasome levels 6, 9 and 12 months following curative treatment for HCC, comparison with AFP levels and results from imaging studies



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01492127


Locations
France
UH Montpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Natalie Funakoshi University Hospital, Montpellier

Publications:
Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01492127     History of Changes
Other Study ID Numbers: UF 8671
First Posted: December 14, 2011    Key Record Dates
Last Update Posted: April 23, 2015
Last Verified: April 2013

Keywords provided by University Hospital, Montpellier:
Hepatocellular carcinoma
cirrhosis
proteasome
alpha-fetoprotein

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Fibrosis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Pathologic Processes