Actively Recruiting
PRecocious biOmarkers oF Unilateral ureTero-pelvic jUnction obstRuction in childrEn
Led by University of Campania Luigi Vanvitelli · Updated on 2024-04-30
85
Participants Needed
5
Research Sites
104 weeks
Total Duration
On this page
Sponsors
U
University of Campania Luigi Vanvitelli
Lead Sponsor
U
University of Milan
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to learn about specific biomarkers related to unilateral ureteropelvic junction obstruction (UPJO) in children aged 0 to 5 years who undergo surgery for this condition compared with children without hydronephrosis needing surgery for other reasons. UPJO is a blockage that affects urine flow from the kidney to the ureter, which can cause kidney damage. The study focuses on improving diagnosis and risk assessment through blood and urine tests rather than relying solely on imaging. Children in the study will have urinary single-cell and extracellular vesicle screenings to explore kidney injury and repair processes, along with whole blood gene expression profiling to identify early markers of UPJO. The study will compare data from 35 children with unilateral UPJO and 50 control children who require surgery for other conditions like hernia or hydrocele. The research does not involve treatment but collects diagnostic information. Participants will undergo collection of urine and blood samples over a period of up to 48 months to measure biomarkers. Researchers will analyze these samples to better understand kidney damage mechanisms and improve early diagnosis of UPJO. This long-term observation aims to reduce unnecessary surgeries and the risks of delayed treatment by identifying precise biomarkers. The study is observational and does not involve any experimental therapies.
CONDITIONS
Brief Title
The PRO-FUTURE Project
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Unilateral UPJO
- Age between 0 and 5 years
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 months
Participants undergo urinary single-cell and extracellular vesicles screening, along with whole blood gene expression profiling to identify early biomarkers of unilateral uretero-pelvic junction obstruction.
Periodic assessments depending on disease progression and follow-up schedules
Trial Site Locations
Total: 5 locations
1
Univeristà degli Studi della Campania Luigi Vanvitelli
Naples, Campania, Italy, 80138
Actively Recruiting
2
Department of Clinical Sciences and Community Health, University of Milano
Milan, Italy
Active, Not Recruiting
3
Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico
Milan, Italy
Actively Recruiting
4
Obstetrics and Gynecology Unit, University of Modena and Reggio Emilia
Modena, Italy
Actively Recruiting
5
AORN Santobono-Pausilipon
Naples, Italy
Actively Recruiting
Research Team
P
Pierluigi Marzuillo, MD PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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