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

NCT02898415 | Completed

• 1 other identifier: 156-16
• Study Type: observational
• Target: 1,018
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

HCC; Liver Transplantation; AFP; Mortality; Competing risk; Selection criteria; Recurrence

Outcome Measures

Primary Outcomes (1)

• Cancer specific survival

  5 years

Secondary Outcomes (2)

• Overall Survival

  5 years

• Recurrence Free Survival

  5 years

Study Arms (1)

Training set

Consecutive patients who underwent liver transplantation for HCC at Italian transplant centers

Procedure: Liver transplantation

Interventions

Liver transplantation PROCEDURE

Training set

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing liver transplantation for HCC within or beyond accepted transplant criteria

You may qualify if:

• \> 18-year-old patients with a definite pre-operative diagnosis of HCC (either radiologic or pathologic) who underwent their first LT in Italian tertiary centres for liver cancer, over a period of at least 10 years after 2000;
• Available clinical parameters of HCC (morphology and α-Fetoprotein levels) both in the evaluation process and during their stay within the waiting list;
• Evaluable clinical response to either medical or interventional anti-cancer treatments delivered prior to LT, by means of RECIST criteria (1.1 or mRECIST/EASL);
• Fully described co-morbidities;
• Completed oncologic follow-up (disease recurrence and/or cancer-specific death) and hepatologic/transplant follow-up (liver disease recurrence or onset of non-oncologic disease and/or death from any cause).

You may not qualify if:

• \< 18-year-old patients
• incidentally discovered HCC
• macroscopic invasion of vascular structures
• extra-hepatic spread

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead

Related Publications (1)

• Mazzaferro V, Sposito C, Zhou J, Pinna AD, De Carlis L, Fan J, Cescon M, Di Sandro S, Yi-Feng H, Lauterio A, Bongini M, Cucchetti A. Metroticket 2.0 Model for Analysis of Competing Risks of Death After Liver Transplantation for Hepatocellular Carcinoma. Gastroenterology. 2018 Jan;154(1):128-139. doi: 10.1053/j.gastro.2017.09.025. Epub 2017 Oct 5.

  PMID: 28989060 DERIVED

Related Links

• Survival calculator

MeSH Terms

Conditions

Recurrence

Interventions

Liver Transplantation

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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

• Vincenzo Mazzaferro, MD PhD

  Fondazione IRCCS ISTITUTO NAZIONALE TUMORI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 13, 2016
• Study Start: June 1, 2015
• Primary Completion: March 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 6, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share