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

Kidney Stone Clinical Trial

— PRECILITH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05237063
• Other study ID #: PI2021_843_0137
• Status: Recruiting
• Phase: N/A
• Start date: January 13, 2021
• Est. completion date: February 2031

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Dominique Eladari, Pr
• Phone: 06 13 03 99 01
• Email: dominique.eladari[@]inserm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: February 2031
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Calculi
• Kidney Stone
• Nephrolithiasis
• Recurrence

Intervention

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

Locations

Country	Name	City	State
France	CHU Amiens Nord	Amiens

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens	Institut Pasteur de Lille, Université de Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with nephrolithiasis recurrence within 5 years of follow-up		at 5 years
Secondary	Occurrence of high blood pressure patients		at 1 year
Secondary	Occurrence of high blood pressure patients		at 3 years
Secondary	Occurrence of high blood pressure patients		at 5 years
Secondary	Occurrence of patients with diabetes		at 1 year
Secondary	Occurrence of patients with diabetes		at 3 year
Secondary	Occurrence of patients with diabetes		at 5 year
Secondary	Occurrence of patients with osteopenia	Occurrence of patients with osteopenia during monitoring of bone mineral density with DXA	at 1 year
Secondary	Occurrence of patients with osteopenia	Occurrence of patients with osteopenia during monitoring of bone mineral density with DXA	at 3 year
Secondary	Occurrence of patients with osteopenia	Occurrence of patients with osteopenia during monitoring of bone mineral density with DXA	at 5 year
Secondary	Occurrence of patients with a deterioration in renal function	Occurrence of patients with a deterioration in renal function during follow-up	at 1 year
Secondary	Occurrence of patients with a deterioration in renal function	Occurrence of patients with a deterioration in renal function during follow-up	at 3 year
Secondary	Occurrence of patients with a deterioration in renal function	Occurrence of patients with a deterioration in renal function during follow-up	at 5 year