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Recruiting NCT06544863

NCT06544863 Evaluation of Patient Care Support for Cirrhosis and/or Liver Transplants

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Clinical Trial Summary
NCT ID NCT06544863
Status Recruiting
Phase
Sponsor Assistance Publique - Hôpitaux de Paris
Condition Cirrhosis
Study Type OBSERVATIONAL
Enrollment 3,000 participants
Start Date 2025-03-19
Primary Completion 2040-03-19

Trial Parameters

Condition Cirrhosis
Sponsor Assistance Publique - Hôpitaux de Paris
Study Type OBSERVATIONAL
Phase N/A
Enrollment 3,000
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-03-19
Completion 2040-03-19
Interventions
Data collection; biological samples

Eligibility Fast-Check

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Brief 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 Criteria

Inclusion Criteria: * Age ≥18 years * Patients managed for cirrhosis or suspected cirrhosis and/or TH at Pitié Salpêtrière University Hospital * Patients having been informed and having signed the consent to participate in the study. Exclusion Criteria: * Patient under legal protection (guardianship, curatorship)

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