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NCT Number: NCT06032364

Stone Disease of the Urinary Tract in Children

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.

Recruiting

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Key information

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Pédiatrie 1 - CHU de Strasbourg - France

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Ciro ANDOLFI, MD

PRINCIPAL_INVESTIGATOR

Isabelle TALON, MD

CONTACT

[email protected]

33 3 88 12 72 96

Isabelle TALON, MD

PRINCIPAL_INVESTIGATOR

Kamal EL HAISSOUFI, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

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.

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

    This study is retrospective on already existing data

Study contacts

Contact information is provided by the study sponsor or research team.

Isabelle TALON, MD

CONTACT

[email protected]

33 3 88 12 72 96

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

Stone Disease of the Urinary Tract in Children: Clinical Presentation, Diagnostic Methods, Therapeutic Management, Evolution and Prognosis

Acronym: Ped-Urolithia

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 13, 2023
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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