The PRO-FUTURE Project
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-5
SponsorUniversity of Campania Luigi Vanvitelli
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
unilateral UPJO
0-5years of age
Disqualifiers
bilateral UPJO
previous surgical intervention on the urinary tract
bladder or lower urinary tract symptoms or malformations
nephro- or urolithiasis, vesicoureteral reflux
Trial population
Definition of cases (patients with UPJO): in this project, the investigators define the UPJO as an hydronephrosis needing of surgical correction on the basis of at least 2 of the following criteria: APDP ≥ 30 mm, SRF less than 40% at the Mag3S, SRF with delta \> 10% at follow-up Mag3S compared with the first Mag3S, delayed wash-out following diuretic administration, progressive increase of the APDP at follow-up kidney ultrasounds, 4th degree hydronephrosis. Otherwise, the hydronephrosis will be defined as non-obstructive. Definition of controls: babies aged 0-5 years and needing of surgical correction for hernia, hydrocele or phimosis.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Identification of Diagnostic Biomarkers
Diagnostic testUrinary 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.
Treatment groups
85 Participants
are divided into 2 treatment groupsGroup A: Babies with unilateral UPJO1 intervention
Group B: Controls of babies with unilateral UPJO1 intervention
Trial outcomes
Primary outcomes
1
Urine Biomarkers
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).
Time frame
48 months2
Blood Biomarkers
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).
Time frame
48 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Campania Luigi Vanvitelli
Lead sponsor
University of Milan
Collaborator
A.O.R.N. Santobono-Pausilipon
Collaborator
University of Modena and Reggio Emilia
Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Collaborator
Source ClinicalTrials.gov