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Идёт набор NCT06092385

SASL Swiss Cirrhosis Cohort

— Наблюдательное Liver Cirrhosis

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.
Кому может быть актуально
Состояния в реестре: Liver 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
Швейцария
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

SASL Swiss Cirrhosis Cohort Study

Обзор

This is a national prospective long-term multicentre observational cohort study following patients with cirrhosis in order to systematically and longitudinally record epidemiological, clinical, histological, psychosocial and patient-reported data and biobank biological material from patients with cirrhosis. The central element of all scientific operation and productivity in the Swiss Cirrhosis Cohort Study (SSCiCoS) is the so-called "nested project" (NP). Based on the evolving large pool of data and biological samples, SSCiCoS investigators use the data pool in order to investigate specific hypotheses and questions.

Подробное описание

For patients with end-stage cirrhosis there are no treatment options other than transplantation, a medically and ethically challenging procedure. The challenge therefore is to prevent the need for liver transplantation in as many patients with cirrhosis as possible.

In order to reach this aim, patients with cirrhosis should be identified and followed regularly according to the highest standard of current knowledge. Numerous aspects of the disease need to be detailed: its epidemiology in Switzerland, its pathophysiology including the mechanism of scar tissue generation and resolution, the associated immune dysfunction and subsequent organ failures, disease related psychosocial and behavioural factors, perceived burden of liver cirrhosis in patients, diagnostic and prognostic biomarkers for disease dynamics, both progression and regression of disease, and stage-specific therapeutic strategies.

This is a national prospective long-term multicentre observational cohort study following patients with cirrhosis in order to systematically and longitudinally record epidemiological, clinical, histological, psychosocial and patient-reported data and biobank biological material from patients with cirrhosis.

Вмешательства

  • Другое Data collection
    Clinical assessment and blood sampling at day of inclusion and in 6- monthly intervals for stable cirrhotic patients; at day of inclusion and on days 3, 7, 14 and 28 for acute decompensation or acute-on-chronic liver failure patients; assessment of clinical, psychosocial/behavioural and patient-reported data in parallel with blood sampling; * Biobanking of PBMCs and serum/plasma samples * Biobanking of other biological material if sampled for clinical reasons (liver biopsies, ascites, urine, gu

Первичные конечные точки

  • Change in Number of liver transplantations [Срок оценки: Through study completion, an average of 10 years]
  • Change in Number of survival [Срок оценки: Through study completion, an average of 10 years]
  • Change in Number of transplant free survival [Срок оценки: Through study completion, an average of 10 years]
  • Change in Number of decompensation events [Срок оценки: Through study completion, an average of 10 years]
  • Change in Number of organ failure [Срок оценки: Through study completion, an average of 10 years]
  • Change in Number of infectious complications [Срок оценки: Through study completion, an average of 10 years]
  • Change in Number of maligancies [Срок оценки: Through study completion, an average of 10 years]
  • Change in Patient Reported Outcome Measures (PROMs, e.g. Epworth Sleepiness Scale) [Срок оценки: Through study completion, an average of 10 years]

Критерии участия

Критерии включения

  • A) Patients with chronic liver disease and histologically proven cirrhosis
  • B) Control subjects with no signs of cirrhosis

Критерии исключения

  • Age <18 years
  • patients who developed hepatocellular carcinoma (HCC) and/or cholangiocellular carcinoma (CCC)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Швейцария · 10 центров
  • Gastroenterology and Hepatology, Cantonal Hospital Ticino — Lugano
  • University Centre for Gastrointestinal and Liver Diseases, University Hospital Basel, Swit — Basel
  • Department of Visceral Surgery and Medicine, University Hospital of Berne — Bern
  • Gastroenterology and Hepatology, University Hospital Geneva — Geneva
  • Gastroenterology and Hepatology, Lausanne University Hospital — Lausanne
  • Ticino Liver Centre — Lugano
  • Gastroenterology and Hepatology, Cantonal Hospital St. Gallen — Sankt Gallen
  • Arud Centre for addiction medicine Zurich — Zurich
  • … и ещё 2 центра

Идентификаторы

NCT: NCT06092385 · 2022-01370; bb23Bernsmeier

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗