Prediction of Recurrence and Complications of Nephrolithiasis Using a Precision Medicine Approach
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood and urine samples.
- Who it may be relevant to
- Registry conditions: Kidney Stone, Nephrolithiasis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Biological Blood and urine samples
Additional Blood and urine samples will be collected at inclusion, 1, 3 and 5 years follow up visits
Primary outcome measures
- Number of patients with nephrolithiasis recurrence within 5 years of follow-up [Time frame: at 5 years]
Secondary outcome measures (12)
- Occurrence of high blood pressure patients [Time frame: at 1 year]
- Occurrence of high blood pressure patients [Time frame: at 3 years]
- Occurrence of high blood pressure patients [Time frame: at 5 years]
- Occurrence of patients with diabetes [Time frame: at 1 year]
- Occurrence of patients with diabetes [Time frame: at 3 year]
- Occurrence of patients with diabetes [Time frame: at 5 year]
- Occurrence of patients with osteopenia [Time frame: at 1 year]
- Occurrence of patients with osteopenia [Time frame: at 3 year]
- Occurrence of patients with osteopenia [Time frame: at 5 year]
- Occurrence of patients with a deterioration in renal function [Time frame: at 1 year]
- Occurrence of patients with a deterioration in renal function [Time frame: at 3 year]
- Occurrence of patients with a deterioration in renal function [Time frame: at 5 year]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
France · 1 center
- CHU Amiens Nord — Amiens
Identifiers
NCT: NCT05237063 · PI2021_843_0137