NCT04208035Unknown不适用
Hepatitis C Elimination in the Netherlands (CELINE) - A National Multicenter Cohort Study Retrieving Lost to Follow-up Chronic Hepatitis C Patients
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Number of lost to follow-up (LTFU) patients successfully re-linked to care
研究概览
简要总结
The aim of CELINE is to retrieve and re-evaluate lost to follow-up chronic hepatitis C patients in the Netherlands.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ever diagnosed with (possible) chronic HCV in the 15-year period prior to initiation of the study, defined as having had a positive anti-HCV or HCV RNA test
- •Lost to follow-up, defined as the lack of a scheduled outpatient care appointment after the last known positive HCV test result
排除标准
- •Younger than 18
- •Not residing in the Netherlands
- •Unknown current address
- •Severe comorbidity or short life expectancy that limits patients from benefiting from retrieval
结局指标
主要结局
Number of lost to follow-up (LTFU) patients successfully re-linked to care
时间窗: End of study, on average 2.5 years after initiation
次要结局
- Time of being LTFU(End of study, on average 2.5 years after initiation)
- Reasons for becoming LTFU(End of study, on average 2.5 years after initiation)
- Liver fibrosis stage of retrieved patients(End of study, on average 2.5 years after initiation)
- Total number of LTFU patients in the investigated time period(15 years prior to study initiation)
- Case ascertainment rate(End of study, on average 2.5 years after initiation)
- Awareness of HCV diagnosis among LTFU patients(End of study, on average 2.5 years after initiation)
- Number of patients who never had an outpatient appointment with a hepatologist or infectious disease specialist after initial positive HCV test(End of study, on average 2.5 years after initiation)
- Number of viraemic patients at time of re-evaluation(End of study, on average 2.5 years after initiation)
- Mode of HCV transmission(End of study, on average 2.5 years after initiation)
- Sustained virological response(End of study, on average 2.5 years after initiation)
研究者
Joost Drenth
Professor, MD, PhD
Radboud University Medical Center
研究点 (1)
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