RecruitingNCT06382233

The PRO-FUTURE Project

PRecocious biOmarkers oF Unilateral ureTero-pelvic jUnction obstRuction in childrEn


Sponsor

University of Campania Luigi Vanvitelli

Enrollment

85 participants

Start Date

Jan 30, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

The goal of this observational study is to learn about specific biomarkers of unilateral ureteropelvic junction obstruction (UPJO) in children undergoing surgical intervention for unilateral UPJO compared with controls. The main question it aims to answer are: * Are Urinary single-cell and extracellular vesicles (EVs) screening useful to stage the intrarenal injury and repair processes in UPJO babies? * Do babies with unilateral UPJO have a whole blood gene expression profiling (WBGEP) allowing an accurate unilateral UPJO diagnosis?


Eligibility

Min Age: 1 DayMax Age: 5 Years

Plain Language Summary

Simplified for easier understanding

This study (called PRO-FUTURE) follows infants and young children with a urinary tract blockage called ureteropelvic junction obstruction (UPJO) — where the connection between the kidney and the tube leading to the bladder is narrowed. Researchers want to understand which children will improve on their own versus need surgery. **You may be eligible if...** - Your child has a one-sided (unilateral) UPJO blockage - Your child is between 0 and 5 years old **You may NOT be eligible if...** - Your child has blockages on both sides (bilateral UPJO) - Your child has had previous urinary tract surgery - Your child has bladder problems, kidney stones, or urinary reflux - Your child has a urinary tract infection history Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTIdentification of Diagnostic Biomarkers

Urinary single-cell and EVs screening to stage the intrarenal injury and repair processes in UPJO babies and identification of the whole blood gene expression profiling of babies with unilateral UPJO. Data deriving from patients with unilateral UPJO will be compared with data deriving from controls.


Locations(5)

Univeristà degli Studi della Campania Luigi Vanvitelli

Naples, Campania, Italy

Department of Clinical Sciences and Community Health, University of Milano

Milan, Italy

Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico

Milan, Italy

Obstetrics and Gynecology Unit, University of Modena and Reggio Emilia

Modena, Italy

AORN Santobono-Pausilipon

Naples, Italy

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NCT06382233


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