NCT01389115

Brief Summary

The purpose of this study is to determine lipid metabolism in chronic liver disease in the attempt to find a useful biomarker of liver function and of prognostic value of graft function in those patients who undergo liver transplant. The present study enrolls subjects with liver cirrhosis (with different ethiology), including subjects eligible for a full-size liver transplantation, and healthy controls.

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
320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2001

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

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

July 1, 2001

Completed
9.9 years until next milestone

First Submitted

Initial submission to the registry

May 6, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 7, 2011

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

December 11, 2015

Status Verified

December 1, 2015

Enrollment Period

14.8 years

First QC Date

May 6, 2011

Last Update Submit

December 10, 2015

Conditions

Liver Cirrhosis

Keywords

liver cirrhosisoxidative stressliver transplant

Outcome Measures

Primary Outcomes (1)

  • Post operative graft function after liver transplantation

    • Multiple lipid metabolism biomarkers (fatty acids, cholesterol and oxysterols) are evaluated in the plasma of liver cirrhosis patients before liver transplantation. A logistic regression model is used to evaluate which of these biomarkers is an independent predictor of graft function

    Change in graft function after 7 and 30 days after liver transplantation

Secondary Outcomes (1)

  • Early gene expression in the liver graft

    30 days

Study Arms (3)

Liver Cirrhosis

Patient with liver cirrhosis undergoing liver transplant

Liver donors

Subjects eligible for organ explant

Healthy controls

Eligibility Criteria

Age15 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1. 150 cirrhotic patients, including Hepatocellular Carcinoma (HCC), Hepatitis C Virus (HCV) positive patients 2. 80 healthy controls 3. 100 liver donors

You may qualify if:

  • subjects with liver cirrhosis eligible for liver transplant, and one MELD score determination performed at least 3 months before liver transplantation

You may not qualify if:

  • liver transplant contraindication and re-transplantation
  • current use of antioxidants and fatty acids supplements
  • Healthy controls are recruited recruited among the University personnel, after a review of their medical history.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Clinical Medicine Division of Gastroenterology, Sapienza University of Rome

Rome, RM, 00161, Italy

RECRUITING

Liver Transplant Center Paride Stefanini, Sapienza University of Rome

Rome, RM, 00161, Italy

RECRUITING

Laboratory of Vascular Medicine, Department of Medical Sciences and Biotechnology, Sapienza University of Rome

Latina, 04100, Italy

RECRUITING

Related Publications (8)

  • Poli G. Pathogenesis of liver fibrosis: role of oxidative stress. Mol Aspects Med. 2000 Jun;21(3):49-98. doi: 10.1016/s0098-2997(00)00004-2.

    PMID: 10978499BACKGROUND

  • Loguercio C, Federico A. Oxidative stress in viral and alcoholic hepatitis. Free Radic Biol Med. 2003 Jan 1;34(1):1-10. doi: 10.1016/s0891-5849(02)01167-x.

    PMID: 12498974BACKGROUND

  • Iuliano L, Monticolo R, Straface G, Zullo S, Galli F, Boaz M, Quattrucci S. Association of cholesterol oxidation and abnormalities in fatty acid metabolism in cystic fibrosis. Am J Clin Nutr. 2009 Sep;90(3):477-84. doi: 10.3945/ajcn.2009.27757. Epub 2009 Jul 8.

    PMID: 19587087BACKGROUND

  • Al Sibae MR, Cappell MS. Accuracy of MELD scores in predicting mortality in decompensated cirrhosis from variceal bleeding, hepatorenal syndrome, alcoholic hepatitis, or acute liver failure as well as mortality after non-transplant surgery or TIPS. Dig Dis Sci. 2011 Apr;56(4):977-87. doi: 10.1007/s10620-010-1390-3. Epub 2010 Sep 16.

    PMID: 20844956BACKGROUND

  • Corradini SG, Micheletta F, Natoli S, Iappelli M, Di Angelantonio E, De Marco R, Elisei W, Siciliano M, Rossi M, Berloco P, Attili AF, Diczfalusy U, Iuliano L. High preoperative recipient plasma 7beta-hydroxycholesterol is associated with initial poor graft function after liver transplantation. Liver Transpl. 2005 Dec;11(12):1494-504. doi: 10.1002/lt.20524.

    PMID: 16258953RESULT

  • Iuliano L, Micheletta F, Natoli S, Ginanni Corradini S, Iappelli M, Elisei W, Giovannelli L, Violi F, Diczfalusy U. Measurement of oxysterols and alpha-tocopherol in plasma and tissue samples as indices of oxidant stress status. Anal Biochem. 2003 Jan 15;312(2):217-23. doi: 10.1016/s0003-2697(02)00467-0.

    PMID: 12531208RESULT

  • Corradini SG, Elisei W, De Marco R, Siciliano M, Iappelli M, Pugliese F, Ruberto F, Nudo F, Pretagostini R, Bussotti A, Mennini G, Eramo A, Liguori F, Merli M, Attili AF, Muda AO, Natalizi S, Berloco P, Rossi M. Preharvest donor hyperoxia predicts good early graft function and longer graft survival after liver transplantation. Liver Transpl. 2005 Feb;11(2):140-51. doi: 10.1002/lt.20339.

    PMID: 15666381RESULT

  • Ginanni Corradini S, Zerbinati C, Maldarelli F, Palmaccio G, Parlati L, Bottaccioli AG, Molinaro A, Poli E, Boaz M, Serviddio G, Mennini G, Corsi A, Bianco P, Rossi M, Iuliano L. Plasma fatty acid lipidome is associated with cirrhosis prognosis and graft damage in liver transplantation. Am J Clin Nutr. 2014 Aug;100(2):600-8. doi: 10.3945/ajcn.113.074427. Epub 2014 Jun 25.

    PMID: 24965302DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples and liver biopsy specimens

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stefano Corradini, M.D., Ph.D.

    University of Roma La Sapienza

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefano Corradini, M.D., Ph.D.

CONTACT

+390649972086stefano.corradini@uniroma1.it

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

May 6, 2011

First Posted

July 7, 2011

Study Start

July 1, 2001

Primary Completion

May 1, 2016

Study Completion

September 1, 2016

Last Updated

December 11, 2015

Record last verified: 2015-12

Locations

IT(3)