Prediction of Recurrence and Complications of Nephrolithiasis Using a Precision Medicine Approach (PRECILITH)
Primary Purpose
Kidney Stone, Nephrolithiasis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood and urine samples
Sponsored by
About this trial
This is an interventional screening trial for Kidney Stone focused on measuring Kidney Stone, Nephrolithiasis
Eligibility Criteria
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
Sites / Locations
- CHU Amiens NordRecruiting
Outcomes
Primary Outcome Measures
Number of patients with nephrolithiasis recurrence within 5 years of follow-up
Secondary Outcome Measures
Occurrence of high blood pressure patients
Occurrence of high blood pressure patients
Occurrence of high blood pressure patients
Occurrence of patients with diabetes
Occurrence of patients with diabetes
Occurrence of patients with diabetes
Occurrence of patients with osteopenia
Occurrence of patients with osteopenia during monitoring of bone mineral density with DXA
Occurrence of patients with osteopenia
Occurrence of patients with osteopenia during monitoring of bone mineral density with DXA
Occurrence of patients with osteopenia
Occurrence of patients with osteopenia during monitoring of bone mineral density with DXA
Occurrence of patients with a deterioration in renal function
Occurrence of patients with a deterioration in renal function during follow-up
Occurrence of patients with a deterioration in renal function
Occurrence of patients with a deterioration in renal function during follow-up
Occurrence of patients with a deterioration in renal function
Occurrence of patients with a deterioration in renal function during follow-up
Full Information
NCT ID
NCT05237063
First Posted
February 2, 2022
Last Updated
February 7, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
Institut Pasteur de Lille, Université de Lille
1. Study Identification
Unique Protocol Identification Number
NCT05237063
Brief Title
Prediction of Recurrence and Complications of Nephrolithiasis Using a Precision Medicine Approach
Acronym
PRECILITH
Official Title
Prediction of Recurrence and Complications of Nephrolithiasis Using a Precision Medicine Approach
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2021 (Actual)
Primary Completion Date
February 2026 (Anticipated)
Study Completion Date
February 2031 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
Institut Pasteur de Lille, Université de Lille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Stone, Nephrolithiasis
Keywords
Kidney Stone, Nephrolithiasis
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Blood and urine samples
Intervention Description
Additional Blood and urine samples will be collected at inclusion, 1, 3 and 5 years follow up visits
Primary Outcome Measure Information:
Title
Number of patients with nephrolithiasis recurrence within 5 years of follow-up
Time Frame
at 5 years
Secondary Outcome Measure Information:
Title
Occurrence of high blood pressure patients
Time Frame
at 1 year
Title
Occurrence of high blood pressure patients
Time Frame
at 3 years
Title
Occurrence of high blood pressure patients
Time Frame
at 5 years
Title
Occurrence of patients with diabetes
Time Frame
at 1 year
Title
Occurrence of patients with diabetes
Time Frame
at 3 year
Title
Occurrence of patients with diabetes
Time Frame
at 5 year
Title
Occurrence of patients with osteopenia
Description
Occurrence of patients with osteopenia during monitoring of bone mineral density with DXA
Time Frame
at 1 year
Title
Occurrence of patients with osteopenia
Description
Occurrence of patients with osteopenia during monitoring of bone mineral density with DXA
Time Frame
at 3 year
Title
Occurrence of patients with osteopenia
Description
Occurrence of patients with osteopenia during monitoring of bone mineral density with DXA
Time Frame
at 5 year
Title
Occurrence of patients with a deterioration in renal function
Description
Occurrence of patients with a deterioration in renal function during follow-up
Time Frame
at 1 year
Title
Occurrence of patients with a deterioration in renal function
Description
Occurrence of patients with a deterioration in renal function during follow-up
Time Frame
at 3 year
Title
Occurrence of patients with a deterioration in renal function
Description
Occurrence of patients with a deterioration in renal function during follow-up
Time Frame
at 5 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique Eladari, Pr
Phone
06 13 03 99 01
Email
dominique.eladari@inserm.fr
Facility Information:
Facility Name
CHU Amiens Nord
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique Eladari, Pr
Phone
06 13 03 99 01
Email
dominique.eladari@inserm.fr
First Name & Middle Initial & Last Name & Degree
Amélie Bonnefond, DR
First Name & Middle Initial & Last Name & Degree
Isabelle Fournier, Dr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prediction of Recurrence and Complications of Nephrolithiasis Using a Precision Medicine Approach
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