NCT Number: NCT06544863
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Digestive Surgery Department, Pitié-Salpêtrière Hospital, Paris, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Contact information is provided by the study sponsor or research team.
Assistance Publique - Hôpitaux de Paris
Other
Evaluation of Patient Care Support for Cirrhosis and/or Liver Transplants at Pitié Salpêtrière University Hospital
Acronym: PACCHUPS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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