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NCT03775863

AFP Model and Liver Transplantation.

Completed Last updated 19 December 2018
What this trial tests

trial testing Liver transplantation in Liver Carcinoma in 1,200 participants. Completed in 12 December 2018.

Timeline
11 November 2017
Primary endpoint
12 December 2018
12 December 2018

Quick facts

Lead sponsorAustral University, Argentina
StatusCompleted
Study typeOBSERVATIONAL
Enrollment1,200
Start date11 November 2017
Primary completion12 December 2018
Estimated completion12 December 2018
Sites2 locations across France, Argentina

Drugs / interventions tested

Conditions studied

Sponsor

Austral University, Argentina

Who can join

Eligibility, any sex, with Liver Carcinoma or Liver Transplant Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. R3-AFP score is a new composite tool to refine prediction of hepatocellular carcinoma recurrence after liver transplantation.
    Costentin C, Piñero F, Degroote H, Notarpaolo A, et al · · 2022 · cited 24× · PMID 35360522 · DOI 10.1016/j.jhepr.2022.100445
  2. International study on the outcome of locoregional therapy for liver transplant in hepatocellular carcinoma beyond Milan criteria.
    Degroote H, Piñero F, Costentin C, Notarpaolo A, et al · · 2021 · cited 17× · PMID 34485882 · DOI 10.1016/j.jhepr.2021.100331
  3. AFP score and metroticket 2.0 perform similarly and could be used in a "within-ALL" clinical decision tool.
    Piñero F, Costentin C, Degroote H, Notarpaolo A, et al · · 2023 · cited 11× · PMID 36691474 · DOI 10.1016/j.jhepr.2022.100644
  4. Liver transplantation for hepatocellular carcinoma: impact of expansion criteria in a multicenter cohort study from a high waitlist mortality region.
    Piñero F, Anders M, Boin IF, Chagas A, et al · · 2021 · cited 5× · PMID 33040420 · DOI 10.1111/tri.13767

Verify or expand the search:

Other trials of Liver transplantation

Trials testing the same drug.

Other recruiting trials for Liver Carcinoma

Currently open trials in the same condition.

Other Austral University, Argentina trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03775863.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing