NCT04243772

Brief Summary

Within the CHU Brugmann hospital, a multidisciplinary Renal Lithiasis and Mineral Metabolism clinic has been inaugurated in 2017. During the first months of 2018, the activities of the clinic have been focalized on the pre-analytical and analytical aspects of metabolic work-up. 15 patients are followed on average per week. The clinic is recognized as one of the 24 core centers of the European Nephrolithiasis Network and it is the only clinic included in this network in Belgium. The actual practice of the clinic has been published in a survey regarding current practice patterns of stone centers across Europe. Following this publication, the members of the board of the European Nephrolithiasis Network have put as common effort to standardize the care of kidney stone formers and obtained endorsement to perform a second survey in each core center. The aim of this initiative is to share information from real patients in aggregate form. Each core center practice will be evaluated by the second survey by an analysis of the robustness of clinical, biological, urological and radiological data. The main aim of this project consists in the constitution of a clinical, biological, urological and radiological database of followed patients. This database could be shared in aggregate form by using a specialized coding system for the patients. The database will enable the investigators to:

  • describe the epidemiological and clinico-biological characteristics of the CHU Brugmann patient population
  • gather information about the kidney function outcome
  • analyze and classify identified prolithogenics factors
  • characterize related metabolic disorders (diabetes mellitus, metabolic syndrome, arterial hypertension, chronic kidney diseases, osteoporosis...)
  • identify the patients that could participate in the international trials on kidney stone disease
  • identify the patients that will need a specialized genetic testing.
  • evaluate the impact of the clinic activity and metabolic work-up on the rate of recurrence of kidney stones in the patient population. The obtained data will be compared with the global data from the European Nephrolithiasis Network.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 12, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2023

Completed
Last Updated

April 12, 2024

Status Verified

April 1, 2024

Enrollment Period

4.1 years

First QC Date

January 24, 2020

Last Update Submit

April 11, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Urinary tract stone composition

    Urinary tract stone composition

    3 years

  • Metabolic screen results

    Metabolic screen (fasting blood) results

    3 years

  • 24 hour urine screen results

    24 hour urine screen (first basal urine) results

    3 years

Study Arms (1)

Lithiasic patients

Lithiasic patients of the CHU Brugmann Hospital

Other: Data extraction

Interventions

Data extraction from medical files

Lithiasic patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients of the CHU Brugmann Hospital with active or past history of kidney stone (newly diagnosed or with relapse). Medical file data collection starts from 01 January 2018.

You may qualify if:

  • Active or past history of kidney stone (newly diagnosed or with relapse)
  • Age and sex matched controls from the hospital

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Mohamed El Mallouli

    CHU Brugmann

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of nephrology clinic

Study Record Dates

First Submitted

January 24, 2020

First Posted

January 28, 2020

Study Start

November 12, 2019

Primary Completion

December 12, 2023

Study Completion

December 12, 2023

Last Updated

April 12, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations