The PRO-FUTURE Project

NCT06382233 | Recruiting

• 1 other identifier: PRO-FUTURE project
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 5

Brief 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?

Conditions

Ureteropelvic Junction Obstruction; Chronic Kidney Diseases

Keywords

Ureteropelvic junction obstruction; Biomarkers; Single-Cell; Extracellular vesicles; Congenital anomalies of the kidney and urinary tract

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Babies with unilateral UPJO

Children aged 0-5 years with unilateral UPJO. Unilateral UPJO will be defined 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.

Diagnostic Test: Identification of Diagnostic Biomarkers

Controls of babies with unilateral UPJO

Children aged 0-5 years needing of surgical correction for hernia, hydrocele, phimosis or cryptorchidism.

Diagnostic Test: Identification of Diagnostic Biomarkers

Interventions

Identification of Diagnostic Biomarkers DIAGNOSTIC_TEST

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.

Babies with unilateral UPJO; Controls of babies with unilateral UPJO

Eligibility Criteria

• Age: 1 Day - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• unilateral UPJO
• years of age

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead
• 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

Study Sites (5)

Univeristà degli Studi della Campania Luigi Vanvitelli

Naples, Campania, 80138, 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

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples (3mL) will be collected at the time of pre-surgical kidney function evaluation by serum creatinine measurement in both UPJO patients and controls. Spots of urines (4-5 spots with a total volume of 150-200 mL) will be collected by sterile bag or mid-stream (before sedation) and vesical catheter (during sedation) until the start of surgical intervention. Later, only for UPJO patients, urines will be collected from bladder by sterile bag or mid-stream i) after 7 days from the pyeloplasty, and ii) after 2 months and iii) after 12 months when follow-up kidney ultrasounds will be performed.

MeSH Terms

Conditions

Multicystic renal dysplasia, bilateral; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Pierluigi Marzuillo, MD PhD

CONTACT

00390815665344; pierluigi.marzuillo@unicampania.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 24, 2024
• Study Start: January 30, 2024
• Primary Completion: January 30, 2026
• Study Completion (Estimated): January 30, 2028
• Last Updated: April 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (5)