Clinical trial NCT05237063: Prediction of Recurrence and Complications of Nephrolithiasis Using a Precision Medicine Approach
Official title: Prediction of Recurrence and Complications of Nephrolithiasis Using a Precision Medicine Approach
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Stone
Nephrolithiasis
Keywords: Kidney Stone
Nephrolithiasis
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Institut Pasteur de Lille
name: Université de Lille
First posted: 2022-02-11
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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.


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

Primary outcomes:
measure: Number of patients with nephrolithiasis recurrence within 5 years of follow-up
timeFrame: at 5 years
Secondary outcomes:
measure: Occurrence of high blood pressure patients
timeFrame: at 1 year
measure: Occurrence of high blood pressure patients
timeFrame: at 3 years
measure: Occurrence of high blood pressure patients
timeFrame: at 5 years
measure: Occurrence of patients with diabetes
timeFrame: at 1 year
measure: Occurrence of patients with diabetes
timeFrame: at 3 year
measure: Occurrence of patients with diabetes
timeFrame: at 5 year
measure: Occurrence of patients with osteopenia
timeFrame: at 1 year
measure: Occurrence of patients with osteopenia
timeFrame: at 3 year
measure: Occurrence of patients with osteopenia
timeFrame: at 5 year
measure: Occurrence of patients with a deterioration in renal function
timeFrame: at 1 year
measure: Occurrence of patients with a deterioration in renal function
timeFrame: at 3 year
measure: Occurrence of patients with a deterioration in renal function
timeFrame: at 5 year
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Nord
Study officials:
References: