Evaluation of Patient Care Support for Cirrhosis and/or Liver Transplants
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Data collection; biological samples.
- Кому может быть актуально
- Состояния в реестре: Cirrhosis. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Evaluation of Patient Care Support for Cirrhosis and/or Liver Transplants at Pitié Salpêtrière University Hospital
Обзор
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.
Подробное описание
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.
Вмешательства
- Другое Data collection; biological samples
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
Первичные конечные точки
- Evaluation of survival in cirrhosis and liver transplant patients. [Срок оценки: During patient follow-up, for maximum 9 years]
Вторичные конечные точки (6)
- Assessment of the occurrence of complications (digestive hemorrhage, ascites, hepatic encephalopathy, infections and primary liver cancer) in patients with cirrhosis or liver transplants. [Срок оценки: During patient follow-up, for maximum 9 years]
- Identification of clinico-biological predictors of cirrhosis-related or post-TH complications. [Срок оценки: At inclusion]
- Evaluation of the number of liver transplant patients with cirrhosis-related complications [Срок оценки: During patient follow-up, for maximum 9 years]
- Determination of exosome profile in patients with tumor complication of cirrhosis or post-TH [Срок оценки: During patient follow-up, for maximum 9 years]
- Determination of sex steroid hormone profile during cirrhotic disease or post-TH. [Срок оценки: During patient follow-up, for maximum 9 years]
- Immune status in cirrhotic or post-TH patients (IFN-γ, TNF, IL10, IL12, TGF-β protein and transcriptome profiles ...) [Срок оценки: During patient follow-up, for maximum 9 years]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- Patient under legal protection (guardianship, curatorship)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Франция · 3 центра
- Digestive Surgery Department, Pitié-Salpêtrière Hospital — Paris
- Intensive Care Unit, Pitié Salpêtrière Hospital — Paris
- Pitié Salpêtrière University Hospital — Paris
Идентификаторы
NCT: NCT06544863 · APHP231630