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

NCT05237063 | Recruiting

• 1 other identifier: PI2021_843_0137
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Stone; Nephrolithiasis

Keywords

Kidney Stone; Nephrolithiasis

Outcome Measures

Primary Outcomes (1)

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

  at 5 years

Secondary Outcomes (12)

• 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

Interventions

Blood and urine samples BIOLOGICAL

Additional Blood and urine samples will be collected at inclusion, 1, 3 and 5 years follow up visits

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Pasteur de Lille: collaborator
• Université de Lille: collaborator
• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens Nord

Amiens, 80054, France

RECRUITING

MeSH Terms

Conditions

Kidney Calculi; Nephrolithiasis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Dominique Eladari, Pr

CONTACT

06 13 03 99 01; dominique.eladari@inserm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: February 11, 2022
• Study Start: January 13, 2021
• Primary Completion: February 1, 2026
• Study Completion (Estimated): February 1, 2031
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)