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

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Recruiting
CT.gov ID
NCT05237063
Collaborator
Institut Pasteur de Lille (Other), Université de Lille (Other)
2,000
1
120.6
16.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Blood and urine samples
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2000 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Prediction of Recurrence and Complications of Nephrolithiasis Using a Precision Medicine Approach
Actual Study Start Date :
Jan 13, 2021
Anticipated Primary Completion Date :
Feb 1, 2026
Anticipated Study Completion Date :
Feb 1, 2031

Outcome Measures

Primary Outcome Measures

  1. Number of patients with nephrolithiasis recurrence within 5 years of follow-up [at 5 years]

Secondary Outcome Measures

  1. Occurrence of high blood pressure patients [at 1 year]

  2. Occurrence of high blood pressure patients [at 3 years]

  3. Occurrence of high blood pressure patients [at 5 years]

  4. Occurrence of patients with diabetes [at 1 year]

  5. Occurrence of patients with diabetes [at 3 year]

  6. Occurrence of patients with diabetes [at 5 year]

  7. Occurrence of patients with osteopenia [at 1 year]

    Occurrence of patients with osteopenia during monitoring of bone mineral density with DXA

  8. Occurrence of patients with osteopenia [at 3 year]

    Occurrence of patients with osteopenia during monitoring of bone mineral density with DXA

  9. Occurrence of patients with osteopenia [at 5 year]

    Occurrence of patients with osteopenia during monitoring of bone mineral density with DXA

  10. Occurrence of patients with a deterioration in renal function [at 1 year]

    Occurrence of patients with a deterioration in renal function during follow-up

  11. Occurrence of patients with a deterioration in renal function [at 3 year]

    Occurrence of patients with a deterioration in renal function during follow-up

  12. Occurrence of patients with a deterioration in renal function [at 5 year]

    Occurrence of patients with a deterioration in renal function during follow-up

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Amiens Nord Amiens France 80054

Sponsors and Collaborators

  • Centre Hospitalier Universitaire, Amiens
  • Institut Pasteur de Lille
  • Université de Lille

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT05237063
Other Study ID Numbers:
  • PI2021_843_0137
First Posted:
Feb 11, 2022
Last Update Posted:
Feb 11, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire, Amiens
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 11, 2022