Investigating biomarkers for kidney obstruction in young children
PRecocious biOmarkers oF Unilateral ureTero-pelvic jUnction obstRuction in childrEn
University of Campania Luigi Vanvitelli · NCT06382233
This study is trying to find specific markers in urine and blood that can help doctors better diagnose kidney blockages in young children who need surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 85 (estimated) |
| Ages | 1 Day to 5 Years |
| Sex | All |
| Sponsor | University of Campania Luigi Vanvitelli (other) |
| Locations | 5 sites (Naples, Campania and 4 other locations) |
| Trial ID | NCT06382233 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify specific biomarkers associated with unilateral ureteropelvic junction obstruction (UPJO) in children who require surgical intervention. It compares these biomarkers in affected children to controls, focusing on urinary single-cell and extracellular vesicles to assess kidney injury and repair processes. The study also explores whole blood gene expression profiling to improve the accuracy of UPJO diagnosis. By utilizing biofluids for diagnosis, the study seeks to enhance risk stratification and reduce reliance on traditional imaging techniques.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 0-5 years diagnosed with unilateral ureteropelvic junction obstruction.
Not a fit: Patients with bilateral UPJO or those who have had previous surgical interventions on the urinary tract may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses and better management of kidney obstruction in children, potentially preventing progressive kidney damage.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in utilizing biomarkers for kidney conditions, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * unilateral UPJO * 0-5years of age Exclusion Criteria: * bilateral UPJO * previous surgical intervention on the urinary tract * bladder or lower urinary tract symptoms or malformations * nephro- or urolithiasis, vesicoureteral reflux * urinary tract infections.
Where this trial is running
Naples, Campania and 4 other locations
- Univeristà degli Studi della Campania Luigi Vanvitelli — Naples, Campania, Italy (RECRUITING)
- Department of Clinical Sciences and Community Health, University of Milano — Milan, Italy (ACTIVE_NOT_RECRUITING)
- Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico — Milan, Italy (RECRUITING)
- Obstetrics and Gynecology Unit, University of Modena and Reggio Emilia — Modena, Italy (RECRUITING)
- AORN Santobono-Pausilipon — Naples, Italy (RECRUITING)
Study contacts
- Study coordinator: Pierluigi Marzuillo, MD PhD
- Email: pierluigi.marzuillo@unicampania.it
- Phone: 00390815665344
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ureteropelvic Junction Obstruction, Chronic Kidney Diseases, Ureteropelvic junction obstruction, Biomarkers, Single-Cell, Extracellular vesicles, Congenital anomalies of the kidney and urinary tract