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Metabolic Risk Factors and Stones Composition in Adult Kidney Stone Formers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04243772
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Agnieszka Pozdzik, Brugmann University Hospital

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.


Condition or disease Intervention/treatment
Kidney Stone Other: Data extraction

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Metabolic Risk Factors and Stones Composition in Adult Kidney Stone Formers
Actual Study Start Date : November 12, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Stones

Group/Cohort Intervention/treatment
Lithiasic patients
Lithiasic patients of the CHU Brugmann Hospital
Other: Data extraction
Data extraction from medical files




Primary Outcome Measures :
  1. Urinary tract stone composition [ Time Frame: 3 years ]
    Urinary tract stone composition

  2. Metabolic screen results [ Time Frame: 3 years ]
    Metabolic screen (fasting blood) results

  3. 24 hour urine screen results [ Time Frame: 3 years ]
    24 hour urine screen (first basal urine) results



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243772


Contacts
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Contact: Mohamed El Mallouli 3224752639 mohamed.el.mallouli@ulb.be

Locations
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Belgium
CHU Brugmann Recruiting
Brussels, Belgium, 1020
Contact: Mohamed El Mallouli, MD       mohamed.el.mallouli@ulb.be   
Principal Investigator: Mohamed El Mallouli, MD         
Sponsors and Collaborators
Agnieszka Pozdzik
Investigators
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Principal Investigator: Mohamed El Mallouli CHU Brugmann
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Responsible Party: Agnieszka Pozdzik, Head of nephrology clinic, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT04243772    
Other Study ID Numbers: Metastone study
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi