Prediction of Recurrence and Complications of Nephrolithiasis Using a Precision Medicine Approach (PRECILITH)

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.

Study Overview

• Status: Recruiting
• Conditions: Nephrolithiasis; Kidney Stone
• Intervention / Treatment: Biological: Blood and urine samples

• Study Type: Interventional
• Enrollment (Anticipated): 2000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • Recruiting
    • CHU Amiens Nord

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients with nephrolithiasis recurrence within 5 years of follow-up	at 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of high blood pressure patients		at 1 year
Occurrence of high blood pressure patients		at 3 years
Occurrence of high blood pressure patients		at 5 years
Occurrence of patients with diabetes		at 1 year
Occurrence of patients with diabetes		at 3 year
Occurrence of patients with diabetes		at 5 year
Occurrence of patients with osteopenia	Occurrence of patients with osteopenia during monitoring of bone mineral density with DXA	at 1 year
Occurrence of patients with osteopenia	Occurrence of patients with osteopenia during monitoring of bone mineral density with DXA	at 3 year
Occurrence of patients with osteopenia	Occurrence of patients with osteopenia during monitoring of bone mineral density with DXA	at 5 year
Occurrence of patients with a deterioration in renal function	Occurrence of patients with a deterioration in renal function during follow-up	at 1 year
Occurrence of patients with a deterioration in renal function	Occurrence of patients with a deterioration in renal function during follow-up	at 3 year
Occurrence of patients with a deterioration in renal function	Occurrence of patients with a deterioration in renal function during follow-up	at 5 year

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Collaborators: Institut Pasteur de Lille; Université de Lille

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 13, 2021
• Primary Completion (ANTICIPATED): February 1, 2026
• Study Completion (ANTICIPATED): February 1, 2031

Study Registration Dates

• First Submitted: February 2, 2022
• First Submitted That Met QC Criteria: February 2, 2022
• First Posted (ACTUAL): February 11, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Nephrolithiasis; Kidney Stone
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease Attributes; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Recurrence; Kidney Calculi; Nephrolithiasis
• Other Study ID Numbers: PI2021_843_0137

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No