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

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT06544863
Status
Recruiting
Apply to this trial

Conditions

  • Cirrhosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Data collection; biological samples — OTHER
    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 Details

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.

Key Dates

First listed
Aug 9, 2024
Start date
Mar 19, 2025
Status verified
Mar 2026
Primary completion
Mar 19, 2040
Completion
Mar 19, 2040

Study Design

Enrollment
3,000 participants (estimated)

Arms

  • Arm: Cirrhosis or suspected cirrhosis and/or TH patient
    Patients with a diagnosis or suspected diagnosis of cirrhosis and/or TH managed at Pitié Salpêtrière University Hospital

Primary Outcome Measure

Evaluation of survival in cirrhosis and liver transplant patients. [ Time Frame: During patient follow-up, for maximum 9 years ]

Central Contacts

Related Studies