Swiss Kidney Stone Cohort (SKSC)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,250
- 试验地点
- 6
- 主要终点
- Epidemiological characterization
研究概览
简要总结
The SKSC is a continuous database with the objective of a standardized diagnosis and monitoring of patients with kidney stones as well as the establishment of a Biobank.
详细描述
The objective of this study is multi-site, standardized observation and characterization of kidney stone patients.
Furthermore, an adequate structure should be established for the execution of studies with kidney stone patients, in order to then, if necessary, develop recommendations for useful monitoring or prophylactic measures, as well as new treatment options for kidney stone patients.
A control group of 250 stone-free volunteers matching patients cohort participants for sex and age started recruitment in October 2017 and will serve the purpose of comparison in future studies.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Only patients that meet all of the following inclusion criteria can be included in this study:
- •Signed Declaration of informed consent
- •Male or female
- •Recurrent kidney stone episodes (more than 1) or an individual kidney stone episode with one or several of the following risk factors:
- •The first manifestation at the a minimum age of 25
- •Positive family history
- •Non-calcium oxalate stones
- •Gastrointestinal disorders (e.g. gastric bypass surgery, inflammatory bowel disease, malabsorption etc.)
- •Osteoporosis
- •Nephrocalcinosis
- •Single kidneyness
- •Currently pregnant
- •Metabolic syndrome ( Diabetes Mellitus type I and II )
- •Residual calculi (at least 3 months after the therapy)
- •Bilateral or multiple stones
- •Chronic urinary tract infection
- •Chronic renal failure (eGFR lower than 60 ml/min.)
- •Kidney transplant
排除标准
- •Patients with at least one of the following exclusion criteria may not take part in this study.
- •Not signed Informed Consent form
- •Age below 18 years old
- •For SKSC Control Group
- •Inclusion criteria:
- •Signed Declaration of informed consent
- •Male or female
- •Kidney-stone free (screening verification by low-dose CT-scan)
- •Exclusion criteria:
- •Not signed Informed Consent form
- •Age below 18 years old
- •Pregnancy
- •History of kidney stones
- •Low-dose CT-scan positive for kidney stones during screening phase
结局指标
主要结局
Epidemiological characterization
时间窗: 10 years
Epidemiological characterization of kidney stone patients
次要结局
未报告次要终点