NCT01492127

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P25-P50 for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Dec 2011

Typical duration for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 23, 2015

Status Verified

April 1, 2013

Enrollment Period

2.2 years

First QC Date

December 12, 2011

Last Update Submit

April 22, 2015

Conditions

Hepatocellular CarcinomaCirrhosis

Keywords

Hepatocellular carcinomacirrhosisproteasomealpha-fetoprotein

Outcome Measures

Primary Outcomes (1)

  • Variation of plasma proteasome

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

    3 months afterwards

Secondary Outcomes (1)

  • Variation of plasma proteasome

    6, 9 and 12 months

Study Arms (1)

Blood test

NO INTERVENTION

Blood test :carcinoma in cirrhotic patients

Biological: Blood test

Interventions

Blood testBIOLOGICAL

Blood test

Blood test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH Montpellier

Montpellier, 34295, France

Location

Related Publications (1)

  • 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.

    PMID: 19201777BACKGROUND

MeSH Terms

Conditions

Carcinoma, HepatocellularFibrosis

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Natalie Funakoshi

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2011

First Posted

December 14, 2011

Study Start

December 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2016

Last Updated

April 23, 2015

Record last verified: 2013-04

Locations

FR(1)