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RecruitingNCT06032364Ped-UrolithiaUpdated Nov 5, 2024

Stone Disease of the Urinary Tract in Children

An observational study in Urinary Lithiasis, sponsored by University Hospital, Strasbourg, France. Recruiting at 1 site in France. Open to participants aged 1 Year to 17 Years. Per ClinicalTrials.gov, last updated 2024-11-05.

Sponsored by University Hospital, Strasbourg, France · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
  • Started Aug 2023; still recruiting 3 years 2 months later.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
140
Ages
1 Year to 17 Years
Sex
All
01

Study summary

The incidence of stone disease of the urinary tract in children is increasingly increasing with a remarkable economic impact for its management.

This incidence is variable according to race, geographic region, socio-economic status and dietary habits.

Oxalo-calcium stones are the most common but the biochemical nature of urinary stones varies depending on the region where those of a phosphatic nature are characterized by a higher incidence in Europe.

The diagnosis is confirmed by imaging. The unprepared abdomen (ASP) has low diagnostic accuracy. The scanner is the reference tool but remains an irradiating examination.

Risk factors for disease recurrence include primarily the presence of an underlying urinary metabolic abnormality and young age. Urinary metabolic abnormalities vary from one study to another.

The understanding of lithogenesis, its evaluation as well as the therapeutic options is essential for adequate and adapted management in the pediatric population.

02

Conditions studied

  • Urinary Lithiasis

Keywords

  • Urinary Lithiasis
  • Stone disease
  • Urolithiasis
  • Urinary Calculi
03

In context

Urolithiasis

253 studies on the registry are indexed under Urolithiasis; 67 are open to participants now.

This study's planned enrollment of 140 is close to the median of 150 across 65 observational studies indexed under Urolithiasis.

Browse Urolithiasis studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 999 studies on the registry; 358 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients aged less than 18 years presenting with lithiasis of the urinary tree in one of the two departments concerned between 01/01/2010 and 12/31/2022

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged less than 18 years.
  • Both sexes.
  • Subjects presenting with lithiasis of the urinary tree in one of the two departments concerned between 01/01/2010 and 12/31/2022
  • Subject not opposing, after information, the reuse of their data for the purposes of this research.
  • Holders of parental authority who do not object, after being informed, to the reuse of their child's data for the purposes of this research.

Exclusion criteria

Exclusion criteria:

  • Subject or holder of parental authority having expressed opposition to participating in the study.
  • Non-usable patient files: insufficient data.
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
140 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Study of the modalities of the therapeutic management of children with urinary stones, retrospective description of the evolutionary aspects and the risk factors associated with recurrence.

    This study is retrospective on already existing data

    Time frame: Files analysed retrospectively from January 01, 2010 to December 31, 2022 will be examined

07

Study locations

1 of 1 sites recruiting
  • Service de Pédiatrie 1 - CHU de Strasbourg - France
    Strasbourg, 67091, France
    Recruiting
    • Isabelle TALON, MD · ContactIsabelle.TALON@chru-strasbourg.fr · 33 3 88 12 72 96
    • Isabelle TALON, MD · Principal investigator
    • Kamal EL HAISSOUFI, MD · Principal investigator
    • Ciro ANDOLFI, MD · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Aug 2023 (actual). Primary completion is estimated for Jun 2025, 22 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 31, 2023
First posted
Sep 13, 2023
StartActual
Aug 23, 2023
Primary completionEst.
Jun 23, 2025
CompletionEst.
Jun 23, 2025
Last update
Nov 5, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06032364
Responsible party
Sponsor
First posted
Sep 13, 2023
Start date
Aug 23, 2023
Primary completion
Jun 23, 2025 (estimated)
Completion
Jun 23, 2025 (estimated)
Last update
Nov 5, 2024

Study contacts

Isabelle TALON, MD
Contact
Isabelle.TALON@chru-strasbourg.fr
33 3 88 12 72 96

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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