ROTTERDAM—The 4th CHANCE Investigator Meeting took place in Rotterdam, The Netherlands on the occasion of the 2023 International Congress of ILTS, ELITA and LICAGE (ILTS 2023). The CHANCE investigator meeting brought together 35 investigators and professionals from 12 countries (Argentina, Austria, Canada, France, Germany, India, Italy, Japan, Spain, The Netherlands, UK, and USA), 22 people attended in person and 13 joined online, to review and discuss project progress and address challenges of patient recruitment and data collection.
The meeting focused on the status of global recruitment with an emphasis on the process of data monitoring carried out by the Data Management Center at EF CLIF. After two years since the first patient was recruited and having passed the milestone of 500 patients last year, the CHANCE study has started to draw promising preliminary results.
We counted with the participation of William Bernal, Intensivist at King's College London, UK, and Co-Principal Investigator in the CHANCE study, who welcomed attendees and gave some opening remarks. Bernal reviewed the sequence of events in the history of CHANCE since the first meeting in 2020, at the beginning of the COVID-19 pandemic. This event had a great impact on recruitment at the start of study with the first patient being recruited in July 2021 in Argentina, the 100th patient in February 2022, and the 500th patient in November 2022 in Brazil. The 2nd CHANCE Investigator meeting was held in June 2022 at the annual congress of the European Association for the Study of the Liver (EASL), International Liver Congress 2022 in London, UK, and the 3rd CHANCE Investigator Meeting took place in November 2022 in Washington D.C.,USA, at The Liver Meeting 2022 organized by the American Association for the Study of Liver Diseases (AASLD). Bernal announced that two more CHANCE Investigator Meetings will be held this year, with the 5th CHANCE Investigator Meeting taking place at the EASL Congress 2023 in June in Vienna, Austria, and the 6th CHANCE Investigator Meeting at The Liver Meeting 2023 towards the end of the year. Bernal reminded attendees about the primary objective of the CHANCE study, a prospective observational study looking at the outcomes of transplantation in patients with advanced acute-on-chronic liver failure (ACLF) – comparing one-year graft patient survival in patients with ACLF grades 2 or 3 at the time of liver transplantation making comparison with decompensated cirrhosis without ACLF, and looking to a further cohort of patients not being listed for liver transplant who also have ACLF 2 or 3. He summarized a series of secondary and exploratory objectives of the CHANCE study. Throughout the study, we are collecting a variety of biological samples, a resource that will be available to participating centers to conduct ancillary studies. Bernal biefly reviewed the organizational structure within CHANCE, acknowledging representation of the European Liver and Intestine Transplant Association (ELITA) – a section of the European Society for Organ Transplantation (ESOT) – and the International Liver Transplant Society (ILTS) in the Steering Committee and Scientific Board within the Core Group.
Next, Bernal presented a breakdown of recruitment by group, continent and country. In reviewing overall time to inclusion in the study from more than 550 patients for which we have almost completed data, he showed that patients are being recruited quickly after listing for liver transplantation and drew some preliminary conclusions on survival and futility after liver transplant when comparing groups and across recruiting regions.
Cristina Sánchez-Garrido, Head of the Data Management Center at EF CLIF, discussed about issues and challenges related to data collection and provided some recommendations to ensure that the data being collected is of the highest quality standards. She stressed that communication among investigators within the hospital and among hospitals within a region can help overcome most of the logistics and organizational challenges investigators may be facing. From the Data Management Center perspective, scheduled periodic calls and training are critical to the success of the study. The Data Management Center has also developed new features and improved performance of the CHANCE electronic case report form in an effort to optimize the functionality of the platform and has allocated more personnel to the project to carry out data monitoring tasks. Sánchez-Garrido provided answers to most frequent asked questions and presented a new infographic that summarizes all potential trajectories for patients enrolled in the CHANCE study that includes the visit schedule within each patient group and provides guidelines to move patients across groups as established by the protocol.
Marina Berenguer, Regional Coordinator and Consultant Hepatologist at Hospital Universitari i Politècnic La Fe, Spain, provided her insights on the importance of professional associations and particularly the ILTS, where she served as President from 2021 to 2022, in providing support to such a large study. "As trusted societies, we have the contact of all transplant centers in Asia where a lot of living-donor liver transplants are performed, and these could not be reached otherwise", said Berenguer. "This has been the role of the ILTS, fostering collaboration across large transplant centers worldwide", she added. She concluded that having good outcomes from the CHANCE study will be beneficial to transplant societies such as ILTS and ESOT–ELITA.
Next, Anna Bosch, General Manager of EF CLIF, highlighted the importance of creating a solid organizational structure behind such an ambitious project to stay focused, where all stakeholders would be represented. Bosch pointed out that appointed Regional Coordinators had played a key role in the CHANCE study particularly in regions outside Europe. Bosch reviewed the lessons learned during the last three years and encourage all CHANCE investigators to staying committed, collaborate and champion for patients with chronic liver disease. Finally, she thanked everyone for participating in the meeting and making the CHANCE study possible.
The CHANCE study is promoted by the 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