VIENNA—On the occasion of the EASL Congress 2023, the 5th CHANCE Investigator Meeting brought together investigators, research nurses, data managers, statisticians and bioinformaticians to review and discuss project progress and address key issues regarding the completion of patient records.
Rajiv Jalan, Scientific Coordinator of the CHANCE study and Scientific Director of EF CLIF, introduced the session providing an overview of past activities and current status of the study.
Next, Thierry Gustot, Principal Investigator of the CHANCE study at CUB Hôpital Erasme, Belgium, presented up-to-date results on survival and stressed the need of the quality of data to be able to answer key questions in the study addressing its primary objective - compare 1 year graft and patient survival rates after liver transplantation in patients with severe acute-on-chronic liver failure (ACLF grade 2 or 3) at the time of liver transplantation with patients with decompensated cirrhosis without ACLF, and transplant-free survival of patients with ACLF grade 2 or 3.
Cristina Sánchez-Garrido, Head of the Data Management Center at EF CLIF, encouraged collaborators in CHANCE to keep up the good work that will ultimately allow for successful results. She acknowledged all people in collaborating centers for their commitment and, particularly, regional coordinators in Latin America for their great contributions to this collaborative research effort.
Flair J. Carrilho, Hospital das Clínicas, University of São Paulo School of Medicine, Brazil, discussed the results from the ACLARA study—the first large investigation outside Europe promoted by EF CLIF aimed at characterizing the prevalence, epidemiology, and mechanism of ACLF in Latin America—and how this experience has help his center and others in the region to recruit a large number of patients in CHANCE. Carrilho explained that Hospital das Clínicas has a long tradition in liver transplantation, having performed the first deceased donor liver transplant in 1968 and the first living donor liver transplant in the world in 1988. A significant number of liver transplants are performed every year in Brazil, but patients with severe ACLF are not granted priority for liver transplantation beyond the model for end-stage liver disease (MELD) score and mortality is high, he said. By participating in the CHANCE study, the goal of the Liver Unit at Hospital das Clínicas is to change this reality. Since February 2022, Hospital das Clínicas is the top recruiting center in CHANCE and the team lead by Alberto Farias, recruited patient no. 500 in the CHANCE study in November 2022. On behalf of Farias and his team, Carrilho explained that their success relies on fast procedure ethical approval, having a dedicated team to carry out clinical studies, state-of-the-art facilities for sample storage and the necessary logistics to ship samples, but above all a high degree of commitment of all members of the team involved.
A final panel discussion chaired by William Bernal, co-Principal Investigator in the CHANCE study at King's College London, UK, dealt with the challenges to collect some data and ensuring the quality of data.
The CHANCE study is promoted by European Foundation for the Study of Chronic Liver Failure.
About the CHANCE study
CHANCE is a multicenter, global, observational study designed to assess the benefit of liver transplantation in patients with acute-on-chronic liver failure (ACLF) grade 2 or grade 3. This study counts with the support of the International Liver Transplantation Society (ILTS) and the European Liver and Intestine Transplant Association (ELITA) to recruit 2000 patients in 80 centers in 27 countries around the world. The primary objective of the CHANCE study is to compare 1-year graft and patient survival rates after liver transplantation in patients with ACLF grade 2 or grade 3 at the time of liver transplantation with patients with decompensation of cirrhosis without ACLF-2 or 3 and transplant-free survival of patients with ACLF-2 or 3 not listed for liver transplantation. The international nature of this study will allow for deep assessments of the potential impact of different precipitating factors of ACLF (e.g., alcohol vs. Hepatitis B virus flare), different types of liver transplantation (deceased donor vs. living donor liver transplantation) and different regional and national allocation systems on transplant outcomes. Beside these clinical objectives, the CHANCE study aims to build a repository of biological samples to explore new biomarkers to predict prognosis on the waiting list and after liver transplantation, and mechanisms of liver and extrahepatic organ recovery.
ClinicalTrials.gov Identifier: NCT04613921
ClinicalTrials.gov Identifier: NCT04613921