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

Not yet recruiting

• Conditions: Cirrhosis
• Interventions: Other: Data collection and blood sample

• Registration Number: NCT06544863
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Cirrhosis is a major challenge for healthcare professionals in France, with a growing prevalence in the country of over 1,500 to 2,500 diagnosed cases per million inhabitants, and the annual discovery of around 150 to 200 new cases per million inhabitants. The main causes of cirrhosis in France are excessive alcohol consumption, chronic viral hepatitis B and C, and metabolic syndrome. In the course of cirrhosis, severe complications can arise, such as digestive hemorrhage, ascites, hepatic encephalopathy, infections and primary liver cancer, requiring frequent hospitalization. These complications are more frequent in advanced cirrhosis, and may require liver transplantation. Around 15,000 deaths occur each year in France due to cirrhosis, affecting relatively young patients with an average age of 55. Currently, 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. In order to improve the prognosis of patients with cirrhosis, several questions remain unanswered, such as the early diagnosis of cirrhosis in at-risk subjects, the identification of cirrhotic patients at high risk of complications, and the search for factors predictive of response to treatment of the various complications. The establishment of biological collections plays an essential role in research into cirrhosis and its complications, as well as the progression to TH and these complications. These biological collections enable the systematic collection and storage of biological samples and clinical data from cirrhosis and/or transplant patients. These resources are crucial for understanding the underlying mechanisms of the disease, identifying new diagnostic and prognostic biomarkers, and developing new therapeutic approaches.The development of a biological collection also offers the possibility of conducting longitudinal studies, tracking the progression of the disease in cirrhosis patients and/or post-TH. This enables a better understanding of risk factors, prognostic determinants and individual variations in disease progression. Thus, cirrhosis care support is constantly evolving, and the follow-up of a prospective cohort makes it possible to evaluate practices, determine prognostic factors and continually improve the management of patients, whether or not they are transplanted.

Study Timeline

• Study First Submitted: 2024-08-05
• Study First Submitted QC: 2024-08-05
• Study First Posted: 2024-08-09
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-04
• Study Start: 2024-12-01
• Primary Completion: 2039-12-01
• Study Completion: 2039-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1600

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.

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Exclusion Criteria

• Patient under legal protection (guardianship, curatorship)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cirrhosis or suspected cirrhosis and/or TH patient	Data collection and blood sample	Patients with a diagnosis or suspected diagnosis of cirrhosis and/or TH managed at Pitié Salpêtrière University Hospital

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Determination of exosome profile in patients with tumor complication of cirrhosis or post-TH	During patient follow-up, for maximum 9 years	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).
Evaluation of the number of liver transplant patients with cirrhosis-related complications	During patient follow-up, for maximum 9 years	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.
Identification of clinico-biological predictors of cirrhosis-related or post-TH complications.	At inclusion	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).
Assessment of the occurrence of complications (digestive hemorrhage, ascites, hepatic encephalopathy, infections and primary liver cancer) in patients with cirrhosis or liver transplants.	During patient follow-up, for maximum 9 years	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.
Immune status in cirrhotic or post-TH patients (IFN-γ, TNF, IL10, IL12, TGF-β protein and transcriptome profiles ...)	During patient follow-up, for maximum 9 years	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).
Determination of sex steroid hormone profile during cirrhotic disease or post-TH.	During patient follow-up, for maximum 9 years	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).

Trial Locations

Locations (1)

Pitié Salpêtrière University Hospital; 🇫🇷 Paris, France