Real-world Elecsys® GAAD Implementation and Validation to Improve Surveillance and Early Detection of HCC

Официальное название

Real-world Elecsys® GAAD Algorithm Implementation and Validation to Improve Surveillance and Early Detection of Hepatocellular Carcinoma

Обзор

Patients with liver cirrhosis are at high risk of developing hepatocellular carcinoma (HCC) which implies significant mortality. At present current surveillance methods detect hepatocellular carcinomas at a late stage resulting in few treatment options for patients and, in the majority of cases, premature death. The goal of this study is to implement Elecsys® GAAD in real-world hepatocellular carcinoma surveillance for those with liver cirrhosis. The main questions it aims to answer are: * Does the introduction of the Elecsys® GAAD algorithm to the surveillance pathway increase early detection of HCC? * Does the introduction of the Elecsys® GAAD algorithm to the surveillance pathway reduce false positive tests and unnecessary confirmatory investigations? * Does the new surveillance pathway improve adherence? Researchers will compare Elecsys® GAAD with standard of care tests to see if it results in earlier detection of hepatocellular carcinoma and will explore potential improvements to the surveillance pathway.

Вмешательства

• Диагностический тест Elecsys® GAAD
  Elecsys® GAAD is a CE marked in vitro diagnostic (IVD) multivariate index assay, intended as an aid in the diagnosis of early-stage HCC. It provides a semi quantitative result by combining in an algorithm the quantitative measurements of Elecsys® AFP (alpha-fetoprotein) and Elecsys® PIVKA-II (protein induced by vitamin K absence II) levels in serum and plasma, with gender and age. Clinical evidence showed that Elecsys® GAAD had high performance in detecting HCC (sensitivity 86.5%), particularly

Первичные конечные точки

• Incidence of hepatocellular carcinoma diagnosis [Срок оценки: 2 years]
• Stage of hepatocellular carcinoma at diagnosis [Срок оценки: 2 years]

Вторичные конечные точки (5)

• Rates of false positives for each combination of diagnostic tests [Срок оценки: 2 years]
• Rates of curative treatment [Срок оценки: 2 years]
• Rates of adherence [Срок оценки: 2 years]
• Rates of discontinuation [Срок оценки: 2 years]
• Survival rates [Срок оценки: 7 years]

Критерии участия

Критерии включения

• Patients with known liver cirrhosis referred into or already under hepatocellular carcinoma surveillance

Критерии исключения

• Pregnancy/breast-feeding.
• Patients who do not have liver cirrhosis
• Patients who already have hepatocellular carcinoma
• Any patient who is unable to understand, retain and weigh information to make an informed decision, will be excluded from the study. The investigators will use every opportunity, including tele-interpretation services to minimise this from happening.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Великобритания · 1 центр

• Manchester University NHS Foundation Trust — Manchester

Идентификаторы

NCT: NCT05971108 · B01938

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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