PRecocious biOmarkers oF Unilateral ureTero-pelvic jUnction obstRuction in childrEn
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Diagnostic test
Study Type: Observational
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?
Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 5
Healthy Volunteers: f
View:
• unilateral UPJO
• 0-5years of age
Locations
Other Locations
Italy
Department of Clinical Sciences and Community Health, University of Milano
ACTIVE_NOT_RECRUITING
Milan
Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico
RECRUITING
Milan
Obstetrics and Gynecology Unit, University of Modena and Reggio Emilia
RECRUITING
Modena
AORN Santobono-Pausilipon
RECRUITING
Naples
Univeristà degli Studi della Campania Luigi Vanvitelli
RECRUITING
Naples
Contact Information
Primary
Pierluigi Marzuillo, MD PhD
pierluigi.marzuillo@unicampania.it
00390815665344
Time Frame
Start Date: 2024-01-30
Estimated Completion Date: 2028-01-30
Participants
Target number of participants: 85
Treatments
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.
Controls of babies with unilateral UPJO
Children aged 0-5 years needing of surgical correction for hernia, hydrocele, phimosis or cryptorchidism.
Related Therapeutic Areas
Sponsors
Collaborators: University of Milan, A.O.R.N. Santobono-Pausilipon, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, University of Modena and Reggio Emilia
Leads: University of Campania Luigi Vanvitelli