NCT06032364

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

August 23, 2023

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 31, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2025

Completed
Last Updated

November 5, 2024

Status Verified

November 1, 2024

Enrollment Period

1.8 years

First QC Date

August 31, 2023

Last Update Submit

November 4, 2024

Conditions

Keywords

Urinary LithiasisStone diseaseUrolithiasisUrinary Calculi

Outcome Measures

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

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

Eligibility Criteria

Age1 Year - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Pédiatrie 1 - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

UrolithiasisUrinary Calculi

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2023

First Posted

September 13, 2023

Study Start

August 23, 2023

Primary Completion

June 23, 2025

Study Completion

June 23, 2025

Last Updated

November 5, 2024

Record last verified: 2024-11

Locations