Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06382233
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-19
Brief Title:
The PRO-FUTURE Project
Sponsor:
University of Campania Luigi Vanvitelli
Organization:
University of Campania Luigi Vanvitelli
Study Overview
Official Title:
PRecocious biOmarkers oF Unilateral ureTero-pelvic jUnction obstRuction in childrEn
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRO-FUTURE
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
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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None