Urinary LithiasisPed-UrolithiaNCT06032364
Stone Disease of the Urinary Tract in Children
An observational study of Urinary Lithiasis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Urinary Lithiasis
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- 23 Aug 2023to 23 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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.
Who cannot join
- Subject or holder of parental authority having expressed opposition to participating in the study.
- Non-usable patient files: insufficient data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Pédiatrie 1 - CHU de Strasbourg - France
Strasbourg, 67091
Isabelle TALON, MD, 33 3 88 12 72 96, Isabelle.TALON@chru-strasbourg.fr
Isabelle TALON, MD
About this study
Official title: Stone Disease of the Urinary Tract in Children: Clinical Presentation, Diagnostic Methods, Therapeutic Management, Evolution and Prognosis
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.
Read more
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.
- Conditions
- Urinary Lithiasis
- Keywords
- Urinary Lithiasis, Stone disease, Urolithiasis, Urinary Calculi
- Medical subject headings
- Urolithiasis, Urinary Calculi
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Files analysed retrospectively from January 01, 2010 to December 31, 2022 will be examined
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start23 Aug 2023
- Primary completion23 Jun 2025 (estimated)
- Study completion23 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary LithiasisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032364
- Sponsor's protocol ID
- 9020
- Acronym
- Ped-Urolithia
- Status last verified
- Nov 2024
- First submitted
- 31 Aug 2023
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stone Disease of the Urinary Tract in Children: Clinical Presentation, Diagnostic Methods, Therapeutic Management, Evolution and Prognosis
- ClinicalTrials.gov ID
- NCT06032364
- Acronym / sponsor ID
- Ped-Urolithia / 9020
- Conditions
- Urinary Lithiasis
- Keywords
- Urinary Lithiasis, Stone disease, Urolithiasis, Urinary Calculi
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 23 Jun 2025 (estimated)
- Study completion
- 23 Jun 2025 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Subject or holder of parental authority having expressed opposition to participating in the study.
- Non-usable patient files: insufficient data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urinary Lithiasis, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabelle TALON, MD (33 3 88 12 72 96, Isabelle.TALON@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.