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Clinical Trial
. 2010 Jul;64(8):1034-41.
doi: 10.1111/j.1742-1241.2010.02414.x.

Design and rationale for the non-interventional Global Investigation of Therapeutic DEcisions in Hepatocellular Carcinoma and Of its Treatment with Sorafenib (GIDEON) study

R Lencioni  1 , J Marrero, A Venook, S-L Ye, M Kudo
Affiliations
Free PMC article
Clinical Trial

Design and rationale for the non-interventional Global Investigation of Therapeutic DEcisions in Hepatocellular Carcinoma and Of its Treatment with Sorafenib (GIDEON) study

R Lencioni et al. Int J Clin Pract. 2010 Jul.
Free PMC article

Abstract

Background: Hepatocellular carcinoma (HCC) is a complicated condition influenced by multiple confounding factors, making optimum patient management extremely challenging. Ethnicity, stage at diagnosis, comorbidities and tumour morphology affect outcomes and vary from region to region, and there is no common language to assess patient prognosis and make treatment recommendations. Despite recent efforts to reduce the incidence of HCC, most patients present with unresectable disease. Non-surgical treatments include ablation, transarterial chemoembolisation and the multikinase inhibitor, sorafenib, but their effects in all patient subgroups are not known and further information is needed to optimise the use of these treatments.

Aims: The Global Investigation of Therapeutic DEcisions in Hepatocellular Carcinoma and Of its Treatment with SorafeNib (GIDEON) study (ClinicalTrials.gov identifier NCT00812175; http://clinicaltrials.gov/) is an ongoing global, prospective, non-interventional study of patients with unresectable HCC who are eligible for systemic therapy and for whom the decision has been taken to treat with sorafenib under real-life practice conditions. The aim of this study is to evaluate the safety and efficacy of sorafenib in different subgroups, especially Child-Pugh B where data are limited.

Discussion: This study will recruit 3000 patients from > 40 countries and follow them for approximately 5 years to compile a large and robust database of information that will be used to analyse local, regional and global differences in baseline characteristics, disease aetiology, treatment practice patterns and treatment outcomes, with a view to improve the knowledge base used to guide physician treatment decisions and to improve patient outcomes.

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Figures

Figure 1
Figure 1
The global reach of GIDEON
Figure 2
Figure 2
An overview of the GIDEON timeline and planned analyses
Figure 4
Figure 4
Overview of the GIDEON safety, efficacy, treatment and baseline patient assessments and end-points
Figure 3
Figure 3
GIDEON patient assessment schedule
See this image and copyright information in PMC

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