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

NCT ID: NCT05237063

Last Updated: 2023-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-13

Study Completion Date

2031-02-28

Brief Summary

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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

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Conditions

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Kidney Stone Nephrolithiasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Interventions

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Blood and urine samples

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Pasteur de Lille

OTHER

Sponsor Role collaborator

Université de Lille

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Amiens Nord

Amiens, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Dominique Eladari, Pr

Role: CONTACT

06 13 03 99 01

Facility Contacts

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Dominique Eladari, Pr

Role: primary

06 13 03 99 01

Other Identifiers

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PI2021_843_0137

Identifier Type: -

Identifier Source: org_study_id

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