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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06382233
Other study ID # PRO-FUTURE project
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 30, 2024
Est. completion date January 30, 2028

Study information

Verified date April 2024
Source University of Campania "Luigi Vanvitelli"
Contact Pierluigi Marzuillo, MD PhD
Phone 00390815665344
Email pierluigi.marzuillo@unicampania.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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?


Description:

Congenital anomalies of the kidney and urinary tract (CAKUT) are the main cause of chronic kidney disease in children. UPJO is the most common CAKUT. It is defined as impeded urine outflow from the renal pelvis to the ureter, which may result in progressive kidney damage (KD). Renal imaging is the current diagnostic approach, even if substantial shortcomings are present to reliably determine a significant obstruction. Consequently, a follow up is often needed with the risk of progressive KD. The main hypothesis of this proposal is that biofluids (whole blood and urine) could allow a more precise diagnosis and risk stratification of unilateral UPJO compared with the available diagnostic techniques. In this project the investigators define the UPJO as an hydronephrosis needing of surgical correction according to 2 of the following criteria: anterior-posterior diameter of the pelvis (APDP) ≥ 30 mm, split renal function (SRF) < 40% at the Tc99mMag3 scintigraphy (Mag3S), SRF with delta > 10% at follow-up Mag3S, delayed wash-out, progressive increase of the APDP at follow-up ultrasounds, and 4th degree hydronephrosis. The investigators will extensively investigate for specific biomarkers of UPJO at different levels. The investigators will focus 1. on the urine by investigating for intrarenal remodeling processes and searching for kidney-specific biomarkers by urinary single-cell and EVs screening (aim 1). Moreover, based on the hitherto revealed capability of blood cells to perceive organ-specific illnesses, 2. the investigators will perform WBGEP of babies with unilateral UPJO to identify early biomarkers of disease progression (aim 2). For the aims 1 and 2, the investigators will enroll 85 patients aged 0-5 years, 35 with unilateral UPJO and 50 controls without hydronephrosis needing surgical correction for hernia, hydrocele or phimosis. This project could improve the management of patients with suspect of UPJO -starting from birth- by a better understanding of the pathophysiological mechanisms underlying KD and by the identification of early biomarkers of obstruction, reducing the costs and the complications related to either a tardive or not needed surgical correction and reducing the risk of KD development.


Recruitment information / eligibility

Status Recruiting
Enrollment 85
Est. completion date January 30, 2028
Est. primary completion date January 30, 2026
Accepts healthy volunteers No
Gender All
Age group 1 Day to 5 Years
Eligibility 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.

Study Design


Intervention

Diagnostic Test:
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.

Locations

Country Name City State
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 Univeristà degli Studi della Campania Luigi Vanvitelli Naples Campania

Sponsors (5)

Lead Sponsor Collaborator
University of Campania "Luigi Vanvitelli" A.O.R.N. Santobono-Pausilipon, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, University of Milan, University of Modena and Reggio Emilia

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 48 months
Primary 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). 48 months
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