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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University Hospital, Montpellier
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01492127
First received: December 12, 2011
Last updated: April 3, 2013
Last verified: April 2013

December 12, 2011
April 3, 2013
December 2011
December 2014   (final data collection date for primary outcome measure)
Variation of plasma proteasome [ Time Frame: 3 months afterwards ] [ Designated as safety issue: No ]
Variation of plasma proteasome levels before curative treatment of HCC and 3 months afterwards
Same as current
Complete list of historical versions of study NCT01492127 on ClinicalTrials.gov Archive Site
Variation of plasma proteasome [ Time Frame: 6, 9 and 12 months ] [ Designated as safety issue: No ]
Variation of plasma proteasome levels 6, 9 and 12 months following curative treatment for HCC, comparison with AFP levels and results from imaging studies
Same as current
Not Provided
Not Provided
 
Evaluation of Proteasome as a Marker of Hepatocellular Carcinoma in Cirrhotic Patients Following Curative Treatment
Evolution of Plasma Proteasome Levels Following Curative Treatment of Hepatocellular Carcinoma in Cirrhotic Patients

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
  • Hepatocellular Carcinoma
  • Cirrhosis
Biological: No apllicable
No apllicable
Other Name: No apllicable
No Intervention: carcinoma in cirrhotic patients
Not applicable
Intervention: Biological: No apllicable
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, Daurès JP, Blanc P. Plasma proteasome level is a reliable early marker of malignant transformation of liver cirrhosis. Gut. 2009 Jun;58(6):833-8. Epub 2009 Feb 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
March 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Natalie FUNAKOSHI 33 4 67 33 70 63 n-funakoshi@chu-montpellier.fr
France
 
NCT01492127
UF 8671
Yes
University Hospital, Montpellier
University Hospital, Montpellier
Not Provided
Principal Investigator: Natalie Funakoshi University Hospital, Montpellier
University Hospital, Montpellier
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP