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

NCT06544863 | Recruiting

• 1 other identifier: APHP231630
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 3

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.

Conditions

Cirrhosis

Keywords

liver transplantation; alcohol; hepatitis B and C; metabolic syndrome

Outcome Measures

Primary Outcomes (1)

• Evaluation of survival in cirrhosis and liver transplant patients.

  Overall survival will be determined by the time between diagnosis and death of patients with cirrhosis or liver transplants.

  During patient follow-up, for maximum 9 years

Secondary Outcomes (6)

• 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

• Identification of clinico-biological predictors of cirrhosis-related or post-TH complications.

  At inclusion

• Evaluation of the number of liver transplant patients with cirrhosis-related complications

  During patient follow-up, for maximum 9 years

• Determination of exosome profile in patients with tumor complication of cirrhosis or post-TH

  During patient follow-up, for maximum 9 years

• Determination of sex steroid hormone profile during cirrhotic disease or post-TH.

  During patient follow-up, for maximum 9 years

Study Arms (1)

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

Other: Data collection; biological samples

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

Cirrhosis or suspected cirrhosis and/or TH patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis or suspected diagnosis of cirrhosis and/or TH managed at Pitié Salpêtrière University Hospital

You may qualify if:

• 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.

You may not qualify if:

• Patient under legal protection (guardianship, curatorship)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (3)

Digestive Surgery Department, Pitié-Salpêtrière Hospital

Paris, 75013, France

RECRUITING

Intensive Care Unit, Pitié Salpêtrière Hospital

Paris, 75013, France

RECRUITING

Pitié Salpêtrière University Hospital

Paris, 75013, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Fibrosis; Hepatitis B; Metabolic Syndrome

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Dominique THABUT, MD, PhD

CONTACT

+33 1 42 17 57 55; dominique.thabut@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 9, 2024
• Study Start: March 19, 2025
• Primary Completion (Estimated): March 19, 2040
• Study Completion (Estimated): March 19, 2040
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

FR (3)