Polycystic Liver Disease Registry (UK)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Map the natural course of PLD
研究概览
简要总结
Multicentre, observational registry studying the natural course of polycystic liver disease.
详细描述
The Polycystic Liver Disease (PLD) registry (UK) is the UK specific part of an international, multicentre, observational registry. The overall international PLD registry is led by Radboud University Medical Center, Nijmegan, Netherlands. Note- please direct any queries about the international registry to the team at Radboud University Medical Center.
All patients with Polycystic Kidney Disease (PKD) with PLD or patients with Isolated (without PKD) Polycystic Liver Disease are eligible for inclusion (>10 liver cysts).
Data will be collected prospectively and retrospectively including a specific validated PLD questionnaire (PLD-Q).
This registry provides us insight in patient characteristics, risk factors, symptoms, quality of life and treatment strategies in the biggest international PLD cohort so far. Results of this registry will be published and shared at national and international congresses.
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
- 是
入选标准
- •Patients with PLD with more than 10 liver cysts
- •Patients with PKD and PLD with more than 10 liver cysts
排除标准
- •Patients with PKD or PLD with less than 10 liver cysts
结局指标
主要结局
Map the natural course of PLD
时间窗: 10 years
To establish the demographics, presence and severity of symptoms (quantified using the validated PLD-Q questionnaire), liver cyst characteristics on imaging (assessed using Qian's classification), biochemical marker abnormalities (including gamma-glutamyl transferase and alkaline phosphatase), rate and nature of complications, need for treatment, change in liver volume in patients with PLD. This data will be collected retrospectively and prospectively from clinical records and the PLD-Q questionnaire.
次要结局
- Determine whether rate of liver growth can be used to predict disease progression(10 years)
- Assess quality of life using the validated PLD questionnaire (PLD-Q)(10 years)
- Elucidate risk factors for developing a complication in PLD(10 years)
- Elucidate elements that affect PLD progression(10 years)
- Compare effectiveness of different therapies(10 years)