AFP Model and Liver Transplantation.

NCT03775863 | Completed DMC

• 1 other identifier: 17-065
• Study Type: observational
• Target: 1,200
• Locations: 2 countries
• Sites: 2

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).

Conditions

Liver Carcinoma; Liver Transplant Disorder

Keywords

Hepatocellular carcinoma; models; allocation; selection

Outcome Measures

Primary Outcomes (1)

• Incidence of recurrent hepatocellular carcinoma after liver transplantation.

  Competing risk regression, SHR (95% CI)

  2003-2012

Secondary Outcomes (1)

• Survival in patients with hepatocellular carcinoma after liver transplantation.

  2003-2012

Study Arms (3)

Latin American multicenter Cohort

Transplanted patients with HCC in LATAM from 2005-2011

Procedure: Liver transplantation

French mutlicenter Cohort

Transplanted patients with HCC in France from 2003-2005

Procedure: Liver transplantation

Italian multicenter Cohort

Transplanted patients with HCC in Italy from 2005-2011

Procedure: Liver transplantation

Interventions

Liver transplantation PROCEDURE

Liver transplantation for patients with hepatocellular carcinoma

Also known as: Locorregional therapy for HCC before liver transplantation.

French mutlicenter Cohort; Italian multicenter Cohort; Latin American multicenter Cohort

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Austral University, Argentina: lead

Study Sites (2)

Universidad Austral

Pilar, Buenos Aires, 1629, Argentina

Location

Henri Mondor Hospital, University of Paris-Est.

Créteil, Paris, France

Location

Related Publications (4)

• Costentin C, Pinero F, Degroote H, Notarpaolo A, Boin IF, Boudjema K, Baccaro C, Podesta LG, Bachellier P, Ettorre GM, Poniachik J, Muscari F, Dibenedetto F, Duque SH, Salame E, Cillo U, Marciano S, Vanlemmens C, Fagiuoli S, Burra P, Van Vlierberghe H, Cherqui D, Lai Q, Silva M, Rubinstein F, Duvoux C; French-Italian-Belgium and Latin American collaborative group for HCC and liver transplantation. R3-AFP score is a new composite tool to refine prediction of hepatocellular carcinoma recurrence after liver transplantation. JHEP Rep. 2022 Feb 2;4(5):100445. doi: 10.1016/j.jhepr.2022.100445. eCollection 2022 May.

  PMID: 35360522 DERIVED

• Degroote H, Pinero F, Costentin C, Notarpaolo A, Boin IF, Boudjema K, Baccaro C, Chagas AL, Bachellier P, Ettorre GM, Poniachik J, Muscari F, Di Benedetto F, Duque SH, Salame E, Cillo U, Gadano A, Vanlemmens C, Fagiuoli S, Rubinstein F, Burra P, Cherqui D, Silva M, Van Vlierberghe H, Duvoux C; French-Italian-Belgium and Latin American collaborative group for HCC and liver transplantation. International study on the outcome of locoregional therapy for liver transplant in hepatocellular carcinoma beyond Milan criteria. JHEP Rep. 2021 Jul 13;3(5):100331. doi: 10.1016/j.jhepr.2021.100331. eCollection 2021 Oct.

  PMID: 34485882 DERIVED

• Maccali C, Chagas AL, Boin I, Quinonez E, Marciano S, Vilatoba M, Varon A, Anders M, Hoyos Duque S, Lima AS, Menendez J, Padilla-Machaca M, Poniachik J, Zapata R, Maraschio M, Chong Menendez R, Munoz L, Arufe D, Figueroa R, Soza A, Fauda M, Perales SR, Vergara Sandoval R, Bermudez C, Beltran O, Arenas Hoyos I, McCormack L, Mattera FJ, Gadano A, Parente Garcia JH, Tani CM, Augusto Carneiro D'Albuquerque L, Carrilho FJ, Silva M, Pinero F. Recurrence of hepatocellular carcinoma after liver transplantation: Prognostic and predictive factors of survival in a Latin American cohort. Liver Int. 2021 Apr;41(4):851-862. doi: 10.1111/liv.14736. Epub 2020 Dec 2.

  PMID: 33217193 DERIVED

• Pinero F, Anders M, Boin IF, Chagas A, Quinonez E, Marciano S, Vilatoba M, Santos L, Hoyos Duque S, Lima AS, Menendez J, Padilla M, Poniachik J, Zapata R, Soza A, Maraschio M, Chong Menendez R, Munoz L, Arufe D, Figueroa R, de Ataide EC, Maccali C, Vergara Sandoval R, Bermudez C, Podesta LG, McCormack L, Varon A, Gadano A, Mattera J, Villamil F, Rubinstein F, Carrilho F, Silva M. Liver transplantation for hepatocellular carcinoma: impact of expansion criteria in a multicenter cohort study from a high waitlist mortality region. Transpl Int. 2021 Jan;34(1):97-109. doi: 10.1111/tri.13767.

  PMID: 33040420 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Liver Transplantation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation

Study Officials

• Federico Piñero, MD, MSCE

  Austral University, Argentina

  PRINCIPAL INVESTIGATOR

• Christophe Duvoux, MD

  Henri Mondor Hospital, University of Paris-Est, Creteil, France.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: UIC staff

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: December 14, 2018
• Study Start: November 11, 2017
• Primary Completion: December 12, 2018
• Study Completion: December 12, 2018
• Last Updated: December 19, 2018

Record last verified: 2018-12

Locations

AR (1); FR (1)