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临床试验/NCT05237063
NCT05237063招募中不适用

Prediction of Recurrence and Complications of Nephrolithiasis Using a Precision Medicine Approach

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2021年1月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
2,000
试验地点
2
主要终点
Number of patients with nephrolithiasis recurrence within 5 years of follow-up

研究概览

简要总结

Nephrolithiasis is a disease caused by the formation of kidney stones in the urinary tract which can then partially or completely obstruct the latter causing an extremely sharp pain called renal colic. In industrialized countries, it affects 10 to 20% of the population, and is the most common kidney disease.The primary objective of this study is to identify the clinical, biological, genetic, molecular and environmental determinants predictive of recurrence of renal lithiasis.

The study follow-up visit schedule corresponds to the visits usually scheduled as part of patient care: 1 year from the inclusion visit (A1), 3 years (A3) then 5 years (A5). Samples for research (additional volume of blood, urine) will be taken by a registered nurse along with the routine check-up samples.Samples intended for research will be sent by staff to the Biobanque de Picardie (CHU Amiens-Picardie) for processing and conservation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (≥18 years old), male or female ,
  • Persons able to understand and object to the information provided (at the discretion of the investigator)
  • Patient affiliated to social security
  • Patient agreeing to sign the informed consent form
  • patient having presented at least one renal colic attack before inclusion

排除标准

  • Pregnant or breastfeeding woman.
  • Persons deprived of liberty,
  • Adults under legal protection guardianship, or curators or unable to express their consent.
  • Patient refusing to participate in the study
  • Patient in an emergency situation

结局指标

主要结局

Number of patients with nephrolithiasis recurrence within 5 years of follow-up

时间窗: at 5 years

次要结局

  • Occurrence of high blood pressure patients(at 5 years)
  • Occurrence of patients with osteopenia(at 5 year)
  • Occurrence of patients with diabetes(at 5 year)
  • Occurrence of patients with a deterioration in renal function(at 5 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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