Evaluation of Patient Care Support for Cirrhosis and/or Liver Transplants
NCT Number: NCT06544863
Acronym: PACCHUPS
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cirrhosis
Interventions: OTHER: Data collection and blood sample
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 1600
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10-01
Completion Date: 2039-10-01
Locations: Pitié Salpêtrière University Hospital, Paris, 75013, France

Summary:
Cirrhosis is a major challenge in France, with a growing prevalence of 1,500 to 2,500 cases per million inhabitants, and the discovery of 150 to 200 new cases per million inhabitants each year. The main causes are alcohol, hepatitis B and C, and metabolic syndrome. Severe complications of cirrhosis, such as digestive hemorrhage, ascites, hepatic encephalopathy, infections and primary liver cancer, require frequent hospitalization and are more common in advanced stages of the disease. Around 15,000 deaths occur each year, affecting relatively young patients with an average age of 55. At the moment, the only treatment for these patients is liver transplantation (LT), although this is not feasible for all patients, and many complications may arise post LT.

Biological collections play an essential role in research, enabling the collection and storage of biological samples and clinical data to understand disease mechanisms and develop new therapeutic approaches or post-transplant follow-up. Longitudinal studies following the course of the disease offer a better understanding of risk factors and prognostic determinants. In this way, cirrhosis care support is constantly evolving, thanks to the evaluation of practices and the continuous improvement of patient care. For patients in whom TH is feasible, biological collections are also important for research and evaluation, and help improve post-TH care.

Primary Outcome Measures: Evaluation of survival in cirrhosis and liver transplant patients., Overall survival will be determined by the time between diagnosis and death of patients with cirrhosis or liver transplants., During patient follow-up, for maximum 9 years
Secondary Outcome Measures: Assessment of the occurrence of complications (digestive hemorrhage, ascites, hepatic encephalopathy, infections and primary liver cancer) in patients with cirrhosis or liver transplants., Patients will be followed longitudinally, and the occurrence and timing of complications (digestive bleeding, ascites, hepatic encephalopathy, infections and primary liver cancer) will be recorded for each patient., During patient follow-up, for maximum 9 years|Identification of clinico-biological predictors of cirrhosis-related or post-TH complications., Clinico-biological and imaging data collected from patients' diagnosis will be correlated with overall survival and the occurrence of complications (digestive hemorrhage, ascites, hepatic encephalopathy, infections and primary liver cancer)., At inclusion|Evaluation of the number of liver transplant patients with cirrhosis-related complications, The number of cirrhotic patients with complications (digestive hemorrhage, ascites, hepatic encephalopathy, infections and primary liver cancer) will then be followed longitudinally, and the number of patients requiring TH for these complications will be collected., During patient follow-up, for maximum 9 years|Determination of exosome profile in patients with tumor complication of cirrhosis or post-TH, Cirrhotic and TH patients will be followed longitudinally with regular sampling to monitor exosome profiles, sex steroid hormones and immune profiles (IFN-γ, TNF, IL10, IL12, TGF-β protein and transcriptomic profiles, etc.) during cirrhotic disease and TH (objectives 4, 5 and 6)., During patient follow-up, for maximum 9 years|Determination of sex steroid hormone profile during cirrhotic disease or post-TH., Cirrhotic and TH patients will be followed longitudinally with regular sampling to monitor exosome profiles, sex steroid hormones and immune profiles (IFN-γ, TNF, IL10, IL12, TGF-β protein and transcriptomic profiles, etc.) during cirrhotic disease and TH (objectives 4, 5 and 6)., During patient follow-up, for maximum 9 years|Immune status in cirrhotic or post-TH patients (IFN-γ, TNF, IL10, IL12, TGF-β protein and transcriptome profiles ...), Cirrhotic and TH patients will be followed longitudinally with regular sampling to monitor exosome profiles, sex steroid hormones and immune profiles (IFN-γ, TNF, IL10, IL12, TGF-β protein and transcriptomic profiles, etc.) during cirrhotic disease and TH (objectives 4, 5 and 6)., During patient follow-up, for maximum 9 years