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

Not Applicable

Recruiting

• Conditions: Kidney Stone; Nephrolithiasis

• Registration Number: NCT05237063
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-13
• Study First Submitted: 2022-02-02
• Study First Submitted QC: 2022-02-02
• Study First Posted: 2022-02-11
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08
• Primary Completion: 2026-02
• Study Completion: 2031-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of patients with nephrolithiasis recurrence within 5 years of follow-up	at 5 years

Secondary Outcome Measures

Name	Time	Method
Occurrence of high blood pressure patients	at 5 years
Occurrence of patients with osteopenia	at 5 year	Occurrence of patients with osteopenia during monitoring of bone mineral density with DXA
Occurrence of patients with diabetes	at 5 year
Occurrence of patients with a deterioration in renal function	at 5 year	Occurrence of patients with a deterioration in renal function during follow-up

Trial Locations

Locations (1)

CHU Amiens Nord; 🇫🇷 Amiens, France