Evaluation of Patient Care Support for Cirrhosis and/or Liver Transplants

Condition(s) studied

Investigational drug(s) / intervention(s)

Data collection; biological samples: In addition to collecting medical data, additional blood samples will be collected in order to create a biological collection and identify biomarkers associated with the occurrence of cirrhosis-related complications, progression to TH and follow-up. Moreover, residual liver tissues from medical procedures (biopsies or surgical specimens) will be collected and analyzed

Study 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.

Eligibility

Primary outcome measure(s)

• Evaluation of survival in cirrhosis and liver transplant patients. — During patient follow-up, for maximum 9 years
  Overall survival will be determined by the time between diagnosis and death of patients with cirrhosis or liver transplants.

Trial sites (3)

More Assistance Publique - Hôpitaux de Paris trials in France

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