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Modeling Cancer-specific Prognosis in Liver Transplantation for Hepatocellular Carcinoma (HCC)

NCT02898415 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1018

Last updated 2017-09-06

No results posted yet for this study

Summary

Liver transplantation (LT) is one of the curative treatment options for patients with HCC associated to chronic liver disease (cirrhosis). All current international guidelines recommend LT for HCC only within pre-defined criteria The use of restrictive criteria to select patients affected by HCC for LT was originally proposed with the Milan criteria. These criteria were based on pathologic assessment of number and size of the HCC nodules on the explanted liver. Subsequently, many authors proposed the expansion of such restrictive criteria (e.g. UCSF, Tumour Volume, Up-To-Seven etc.). All these attempts, based on different combinations of morphologic parameters, have been defined on the pathologic staging of the tumor made on the removed liver, namely after LT, once decision on treatment and treatment itself could not be changed Although post-LT pathology / pre-LT radiology correlation have improved over time, significant biases still affect clinical assessment of HCC stage and no reliable protocols has entered clinical practice yet. In addition, robust evidence indicates that other biological markers of aggressiveness (such as α-Fetoprotein levels and clinical response to bridge therapies) have to be added when evaluating pre-operative variable Although many studies have been conducted, prognostic calculators of cancer-specific survival for HCC patients undergoing an evaluation for LT are not yet available. Such models should be able to provide survival estimates based on pre-treatment oncologic variables.

The main goal of the study is the definition of a cancer-specific prognostic model based on pre-operative features (radiologic staging and α-Fetoprotein levels) of a wide population of patients who underwent LT for HCC.

Considering the competitive risk of cancer-specific mortality and death due to other causes, the investigators aim to redefine the Up-To-Seven criteria, as they were developed on the base of pathologic staging

Conditions

  • HCC
  • Liver Transplantation
  • Alphafetoprotein
  • Mortality
  • Competing Risk
  • Selection Criteria
  • Cancer Recurrence

Interventions

PROCEDURE

Liver transplantation

Sponsors & Collaborators

  • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    lead OTHER

Principal Investigators

  • Vincenzo Mazzaferro, MD PhD · Fondazione IRCCS ISTITUTO NAZIONALE TUMORI

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2016-03-31
Completion
2016-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02898415 on ClinicalTrials.gov