Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06544863
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-05
Brief Title:
Evaluation of Patient Care Support for Cirrhosis Andor Liver Transplants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of Patient Care Support for Cirrhosis Andor Liver Transplants At Pitié Salpêtrière University Hospital
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PACCHUPS
Brief Summary:
Cirrhosis is a major challenge in France with a growing prevalence of 1500 to 2500 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 15000 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
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 1500 to 2500 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 15000 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 andor transplant patients These resources are crucial for understanding the underlying mechanisms of the disease identifying new diagnostic and prognostic biomarkers and developing new therapeutic approachesThe development of a biological collection also offers the possibility of conducting longitudinal studies tracking the progression of the disease in cirrhosis patients andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None