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AFP Model and Liver Transplantation.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03775863
Recruitment Status : Completed
First Posted : December 14, 2018
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Maria Julia Cremona, Austral University, Argentina

Brief Summary:

Background & Aim: Presence of microvascular invasion (mvi) in the explanted liver defines a higher risk of recurrence of hepatocellular carcinoma (HCC) after liver transplantation (LT). The aim of this study is to evaluate pre LT selection models of HCC recurrence specifically in patients without mvi in the explanted liver.

Methods: Three multicenter cohorts are going to be included: a Latin American, a French and an Italian cohort of consecutive adult patients with HCC a first LT performed during two different periods: 2005-2011 and 2012-2016. AFP model is going to be compared against Milan and San Francisco criteria according to each models accuracy and prediction of HCC recurrence among patients without microvascular invasion in the explanted liver considering these candidates as "Low-risk patients". Multivariate Cox regression analysis, with hazard ratios (HR) and 95% confidence intervals (CI) for 5-year recurrence is going to be done with Competing Risk Regression analysis and corresponding Subhazard Ratios (SHR).


Condition or disease Intervention/treatment
Liver Carcinoma Liver Transplant Disorder Procedure: Liver transplantation

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Study Type : Observational
Actual Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the AFP Model in Predicting Recurrence of Hepatocellular Carcinoma After Liver Transplantation in Patients Without Microvascular Invasion.
Actual Study Start Date : November 11, 2017
Actual Primary Completion Date : December 12, 2018
Actual Study Completion Date : December 12, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Latin American multicenter Cohort
Transplanted patients with HCC in LATAM from 2005-2011
Procedure: Liver transplantation
Liver transplantation for patients with hepatocellular carcinoma
Other Name: Locorregional therapy for HCC before liver transplantation.

French mutlicenter Cohort
Transplanted patients with HCC in France from 2003-2005
Procedure: Liver transplantation
Liver transplantation for patients with hepatocellular carcinoma
Other Name: Locorregional therapy for HCC before liver transplantation.

Italian multicenter Cohort
Transplanted patients with HCC in Italy from 2005-2011
Procedure: Liver transplantation
Liver transplantation for patients with hepatocellular carcinoma
Other Name: Locorregional therapy for HCC before liver transplantation.




Primary Outcome Measures :
  1. Incidence of recurrent hepatocellular carcinoma after liver transplantation. [ Time Frame: 2003-2012 ]
    Competing risk regression, SHR (95% CI)


Secondary Outcome Measures :
  1. Survival in patients with hepatocellular carcinoma after liver transplantation. [ Time Frame: 2003-2012 ]
    Cox regression multivariable adjusted models, HR (95% CI)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sampling Method:   Non-Probability Sample
Study Population
Study design, setting and participating centers This study is going to include three multicenter cohorts of consecutive adult patients (>17 years of age) who underwent a first LT between January 1 2005 and December 31 2016. Participating centers will appoint a study coordinator responsible for data collection. In cases of conflicting or missing data, central revision and resubmission were requested. All the requested variables are going to be included in a written CRF.
Criteria

Inclusion Criteria:

. Criteria for inclusion required patients to be adult cirrhotic or non-cirrhotic recipients with confirmed HCC in the explanted liver.

Exclusion Criteria:

  • other tumors than HCC are confirmed in the explanted liver,
  • there are missing relevant information;
  • extrahepatic or macrovascular tumor invasion were observed during pre transplant evaluation or in the explanted liver
  • incidental HCC,
  • had a previous liver transplant

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): NCT03775863


Locations
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Argentina
Universidad Austral
Pilar, Buenos Aires, Argentina, 1629
France
Henri Mondor Hospital, University of Paris-Est.
Creteil, Paris, France
Sponsors and Collaborators
Austral University, Argentina
Investigators
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Principal Investigator: Federico Piñero, MD, MSCE Austral University, Argentina
Study Director: Christophe Duvoux, MD Henri Mondor Hospital, University of Paris-Est, Creteil, France.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Maria Julia Cremona, UIC staff, Austral University, Argentina
ClinicalTrials.gov Identifier: NCT03775863    
Other Study ID Numbers: 17-065
First Posted: December 14, 2018    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Julia Cremona, Austral University, Argentina:
Hepatocellular carcinoma
models
allocation
selection
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Liver Extracts
Hematinics