Evaluating the Diagnostic and Predictive Value of Non-invasive Tests (NITs) on the Progression of Chronic Liver Disease.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
Primary objective is to study the relevance of non-invasive test (NITs) in predicting disease stage (diagnostic biomarker) and outcome (predictive biomarker) in patients with suspected or established liver disease and cirrhosis.
详细描述
Non-invasive tests (NITs) may complement and even reduce the need for liver biopsy in the diagnosis and follow up care of patients with chronic liver disease (CLD). NITs either include serum biomarkers (direct or indirect) or ultrasound-based tests, including vibration controlled transient elastography (VCTE), or a combination of both incorporated into several surrogate scores.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Clinically suspected chronic liver disease based on any of:
- •Patient with historical liver biopsy providing histological evidence of any liver disease or,
- •Patient undergoing liver biopsy for suspected chronic liver disease with biochemical and/or radiological findings consistent with liver disease or,
- •Patient with clinical and radiological evidence of cirrhosis (in absence of an alternative aetiology)
- •Patients with metabolic risk factors predisposing to CLD
排除标准
- •Refusal or inability (lack of capacity) to give informed consent.
- •Age < 18 years
- •An active malignancy.
- •Life expectation of < 5 years.
- •Patients not meeting inclusion criteria or judged by the investigator to be unsuitable for inclusion in the study.
结局指标
主要结局
Overall survival
时间窗: 10 years
The primary objective of this observational study is to assemble a cohort of well-characterised patients with chronic liver disease (CLD) and to collect associated clinical information, biological samples and imaging data for cross-sectional and longitudinal analyses in order to robustly validate diagnostic and predictive non-invasive tests (NITs) for the diagnosis, risk assessment (prognosis) and monitoring of patients with liver disease. The primary outcome will be overall survival.
次要结局
- Liver-related events(10 years)
研究者
Jörn M. Schattenberg
Prof. Dr.
Johannes Gutenberg University Mainz