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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05237063
Acronym
PRECILITH
Enrollment
2000
Registered
2022-02-11
Start date
2021-01-13
Completion date
2031-02-28
Last updated
2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Stone, Nephrolithiasis

Keywords

Kidney Stone, Nephrolithiasis

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.

Interventions

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

Sponsors

Institut Pasteur de Lille
CollaboratorOTHER
Université de Lille
CollaboratorOTHER
Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of patients with nephrolithiasis recurrence within 5 years of follow-upat 5 years

Secondary

MeasureTime frameDescription
Occurrence of patients with a deterioration in renal functionat 1 yearOccurrence of patients with a deterioration in renal function during follow-up
Occurrence of patients with diabetesat 1 year
Occurrence of patients with osteopeniaat 1 yearOccurrence of patients with osteopenia during monitoring of bone mineral density with DXA
Occurrence of high blood pressure patientsat 1 year

Countries

France

Contacts

Primary ContactDominique Eladari, Pr
dominique.eladari@inserm.fr06 13 03 99 01

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026