Detecting Liver Fibrosis in Patients At-risk
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of non-invasive diagnostic algorithms for identification of advanced liver fibrosis
研究概览
简要总结
The project will establish a research cohort (called STELIR; STEatotisk Liver-risk In Rogaland) based on a biobank with an associated health register. The purpose is to collect, store and analyze biological material and clinical data from people at risk of steatotic liver disease (fatty liver disease). The research cohort will consist of individuals who agree to participate and will be followed over many years with planned examinations/tests at baseline, after 2 years, after 5 years and every 5 years thereafter. The STELIR cohort consists of individuals between 40 and 70 years of age who have one or more of the following risk factors: Obesity, type 2 diabetes or hazardous or harmful alcohol consumption.
The biological material and clinical data collected will be stored and used for research on liver-related disease risk, diagnostics and treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 to 70 years at the time of inclusion
- •At least one of the following risk factors: Overweight or obesity, type 2 diabetes mellitus, risky or harmful alcohol consumption
- •Ability to provide written informed consent
排除标准
- •Inability to give informed consent
- •Individuals outside the defined age range
- •Other conditions precluding participation based on investigator assessment
研究组 & 干预措施
STELIR Cohort
Participants enrolled in the STELIR (STEatotic LIver Risk in Rogaland) cohort will be followed longitudinally as part of an observational research biobank. The cohort includes adults at increased risk of steatotic liver disease based on predefined metabolic and lifestyle risk factors.
No intervention is assigned. Participants undergo standardized clinical assessments and biological sample collection as part of routine study procedures.
干预措施: Routine study procedure (Other)
结局指标
主要结局
Diagnostic accuracy of non-invasive diagnostic algorithms for identification of advanced liver fibrosis
时间窗: Baseline
Area under the receiver operating characteristic curve (AUROC) of non-invasive diagnostic algorithms (combinations of clinical variables, blood-based biomarkers, and liver elastography) for identification of advanced liver fibrosis in individuals at risk of steatotic liver disease.
次要结局
未报告次要终点
研究者
Torgeir Gilje Lid
Research leader and professor of general practice
Helse Stavanger HF