protocolSection identificationModule nctId: NCT06382233, orgStudyIdInfo id: PRO-FUTURE project, briefTitle: The PRO-FUTURE Project, acronym: PRO-FUTURE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-30, primaryCompletionDateStruct date: 2026-01-30, completionDateStruct date: 2028-01-30, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: University of Campania "Luigi Vanvitelli", class: OTHER, collaborators name: University of Milan, collaborators name: A.O.R.N. Santobono-Pausilipon, collaborators name: University of Modena and Reggio Emilia, collaborators name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, descriptionModule briefSummary: 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?, conditionsModule conditions: Ureteropelvic Junction Obstruction, conditions: Chronic Kidney Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 85, type: ESTIMATED, armsInterventionsModule interventions name: Identification of Diagnostic Biomarkers, outcomesModule primaryOutcomes measure: Urine Biomarkers, primaryOutcomes measure: Blood Biomarkers, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 5 Years, stdAges: CHILD, contactsLocationsModule locations facility: Univeristà degli Studi della Campania Luigi Vanvitelli, status: RECRUITING, city: Naples, state: Campania, zip: 80138, country: Italy, contacts name: Pierluigi Marzuillo, role: CONTACT, contacts name: Pierluigi Marzuillo, role: PRINCIPAL_INVESTIGATOR, contacts name: Paolo Montaldo, role: PRINCIPAL_INVESTIGATOR, contacts name: Carmine Noviello, role: PRINCIPAL_INVESTIGATOR, contacts name: Alfonso Papparella, role: SUB_INVESTIGATOR, contacts name: Stefano Guarino, role: SUB_INVESTIGATOR, contacts name: Anna Di Sessa, role: SUB_INVESTIGATOR, contacts name: Grazia Cirillo, role: SUB_INVESTIGATOR, contacts name: Giusy Capasso, role: SUB_INVESTIGATOR, geoPoint lat: 40.85216, lon: 14.26811, locations facility: Department of Clinical Sciences and Community Health, University of Milano, status: ACTIVE_NOT_RECRUITING, city: Milan, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico, status: RECRUITING, city: Milan, country: Italy, contacts name: Giovanni Montini, role: CONTACT, contacts name: Giovanni Montini, role: PRINCIPAL_INVESTIGATOR, contacts name: Alfredo Berrettini, role: PRINCIPAL_INVESTIGATOR, contacts name: Michele Gnech, role: SUB_INVESTIGATOR, geoPoint lat: 45.46427, lon: 9.18951, locations facility: Obstetrics and Gynecology Unit, University of Modena and Reggio Emilia, status: RECRUITING, city: Modena, country: Italy, contacts name: Giovanni Grandi, role: CONTACT, contacts name: Giovanni Grandi, role: PRINCIPAL_INVESTIGATOR, contacts name: Stefano Puliatti, role: SUB_INVESTIGATOR, geoPoint lat: 44.64783, lon: 10.92539, locations facility: AORN Santobono-Pausilipon, status: RECRUITING, city: Naples, country: Italy, contacts name: Giovanni Di Iorio, role: CONTACT, contacts name: Giovanni Di Iorio, role: PRINCIPAL_INVESTIGATOR, contacts name: Agnese Roberti, role: SUB_INVESTIGATOR, geoPoint lat: 40.85216, lon: 14.26811, hasResults: False