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Идёт набор NCT05541601

Prospective Cohort for Early Detection of Liver Cancer

— Наблюдательное Cirrhosis Hepatocellular Carcinoma

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: Blood and Urine samples.
Кому может быть актуально
Состояния в реестре: Cirrhosis, Hepatocellular Carcinoma. Базовые параметры: 18 лет — 100 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
Великобритания
Следующий шаг
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Обзор

This study aims to recruit 3000 people with liver cirrhosis into a Prospective cohort for early detection of Liver cancer - the Pearl cohort. The study team believe that using a combination of novel tests may improve the detection of early Hepatocellular Carcinoma (HCC).

Подробное описание

During a four-year follow-up period, around 100 Pearl patients are expected to be diagnosed with HCC. Blood, urine, clinical and imaging data will be collected over the follow up period. The samples will be used to identify a range of tests (including genetic, protein and other biomarkers), which along with the clinical data will hopefully identify those most at risk of developing HCC, and to identify HCC at the earliest possible time points.

Вмешательства

  • Другое Blood and Urine samples
    The samples will be used to identify a range of tests (including genetic, protein and other biomarkers), which along with the clinical data will hopefully identify those most at risk of developing HCC, and to identify HCC at the earliest possible time points.

Первичные конечные точки

  • Sensitivity of novel diagnostic approaches for the early diagnosis of HCC in enrolled patients who are diagnosed with HCC by conventional approaches. [Срок оценки: When 50 cases of HCC have accumulated through to study completion; up to 5 years]
  • Specificity of novel diagnostic approaches for the early diagnosis of HCC in enrolled patients who are diagnosed with HCC by conventional approaches. [Срок оценки: When 50 cases of HCC have accumulated through to study completion; up to 5 years]
  • Positive/Negative predictive values of novel diagnostic approaches for the early diagnosis of HCC in enrolled patients who are diagnosed with HCC by conventional approaches. [Срок оценки: When 50 cases of HCC have accumulated through to study completion; up to 5 years]
Вторичные конечные точки (2)
  • To develop models that can be used to "risk-stratify" cirrhosis patients according to their future risk of HCC [Срок оценки: Throughout study to completion; 5 years]
  • To better understand the incidence of HCC in a UK population stratified by underlying cirrhosis aetiology [Срок оценки: At 1, 3 and 5 year post- baseline.]

Критерии участия

Критерии включения

  • Patients of all genders, age >18 years
  • Participant is willing and able to give informed consent for participation in the study.
  • Evidence of cirrhosis CP A or B (as defined below, cirrhosis ever diagnosed), with an underlying aetiology of at least one of the following: chronic Hepatitis B Virus (HBV) infection, chronic Hepatitis C Virus (HCV) infection, alcoholic liver disease, non-alcoholic fatty liver disease or haemochromatosis

Cirrhosis Diagnosis Definition

  • Histological assessment (Ishak stage 5 or 6) or
  • At least one of the following:

i. Validated non-invasive marker of fibrosis including fibroscan, AST to Platelet Ratio Index (APRI) score >2 or Enhanced Liver Fibrosis (ELF) score >10.48 or Fibrotest score >0.73. Fibroscan readings should be assessed by aetiology as below:

  • HBV: >=10 kPa
  • HCV: >=14.5 kPa
  • Alcoholic Liver Disease (ALD): >=19.5 kPa
  • Non-alcoholic fatty liver disease (NAFLD): >=15 kPa
  • Haemochromatosis: >=12kPa ii. Evidence of varices at endoscopy or imaging in the context of a patent portal vein iii. Definitive radiological evidence of cirrhosis (i.e. nodularity of liver and splenomegaly on Ultrasound/CT)

Критерии исключения

  • Diagnosis of current OR historical hepatocellular carcinoma
  • Liver transplant recipients or patients on active listing for liver transplantation
  • Child-Pugh C cirrhosis
  • In the view of the clinician, if the patient has a co-morbidity likely to lead to death within the following 12 months
  • In the view of the clinician, if the patient was not thought to be suitable for HCC surveillance

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Великобритания · 1 центр
  • Hepatology Clinical Trial Unit, John Radcliffe Hospital — Oxford

Публикации

  • Khanna K, Barnes E, Benselin J, Culver E, Irving W, Innes H, Pavlides M, Consortium D. Prospective cohort for early detection of liver cancer (Pearl): a study protocol. BMJ Open. 2024 Oct 1;14(10):e085541. doi: 10.1136/bmjopen-2024-085541. PMID 39353693

Идентификаторы

NCT: NCT05541601 · Pearl

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗