The PRO-FUTURE Project

NCT06382233 · tracked via the Priya Life Science Italy tracker

Sponsor

University of Campania Luigi Vanvitelli

Phase

Observational

Started

2024-01-30

Last updated

2024-04-30

Condition(s) studied

Ureteropelvic Junction ObstructionChronic Kidney Diseases

Investigational drug(s) / intervention(s)

Identification of Diagnostic Biomarkers

Identification 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.

Study 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

Sex

ALL

Min age

1 Day

Max age

5 Years

Healthy volunteers

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.

Primary outcome measure(s)

Urine Biomarkers — 48 months
The investigators will focus on the urine by investigating for intrarenal remodeling processes and searching for kidney-specific biomarkers by urinary single-cell and EVs screening (aim 1).
Blood Biomarkers — 48 months
Moreover, based on the hitherto revealed capability of blood cells to perceive organ-specific illnesses, the investigators will perform WBGEP of babies with unilateral UPJO to identify early biomarkers of disease progression (aim 2).

Trial sites (5)

Facility	City	Region	Status
Univeristà degli Studi della Campania Luigi Vanvitelli	Naples	Campania	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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06382233 on ClinicalTrials.gov ↗ ← All trials in Italy