protocolSection identificationModule nctId: NCT06312150, orgStudyIdInfo id: BETA 3 2019, briefTitle: Role of Tumoral Biomarker B3 Adrenergic Receptor in Paediatric Solid Tumours, statusModule overallStatus: RECRUITING, startDateStruct date: 2019-12-17, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-12, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-18, sponsorCollaboratorsModule leadSponsor name: Meyer Children's Hospital IRCCS, class: OTHER, descriptionModule briefSummary: Childhood cancers are the third leading cause of death among children between the ages of 1 and 4, and the second leading cause of death among children aged 5-14 years. Biologically, it has been demonstrated that tumour aggressiveness and invasive capacity are caused by genetic modifications and cellular microenvironmental factors in a sequential and multifactorial process. The search for genetic alterations, proteins, or entire intracellular signalling pathways involved in the process of carcinogenesis and metastatisation is always evolving in order to identify new prognostic factors or potential therapeutic targets. In recent years, β-adrenergic receptors (β-ARs) have been associated with tumour progression.This is a multicentre biological samples study which main aim is to evaluate the β3 receptor expression in the peripheral blood of patients with solid tumours compared to a healthy control group. The biological samples collected during the study are: peripheral blood sample, bone marrow aspirate and fresh or fresh paraffin biopsy tumour., conditionsModule conditions: Tumor, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Analysis of peripheral blood (control group), interventions name: Analysis of biological sample (Substudy-solid neoplasms), interventions name: Analysis of biological sample (substudy-leukaemia patients), outcomesModule primaryOutcomes measure: Evaluation of β3 receptor expression in the peripheral blood, bone marrow and bioptic samples of patients with solid tumours compared to a healthy control group, primaryOutcomes measure: Assessment of oxidative stress in peripheral blood samples from enrolled patients, secondaryOutcomes measure: Evaluation of the role of the β3 receptor in apoptosis resistance (substudy), eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 75 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ospedale San Donato di Arezzo, status: NOT_YET_RECRUITING, city: Arezzo, country: Italy, contacts name: Carlo Milandri, role: CONTACT, email: carlo.milandri@uslsudest.toscana.it, geoPoint lat: 43.46276, lon: 11.88068, locations facility: Meyer Children's Hospital IRCCS, status: RECRUITING, city: Florence, country: Italy, contacts name: Annalisa Tondo, role: CONTACT, phone: 0555662489, email: annalisa.tondo@meyer.it, geoPoint lat: 43.77925, lon: 11.24626, locations facility: Azienda Ospedaliera Pisana, status: ACTIVE_NOT_RECRUITING, city: Pisa, country: Italy, geoPoint lat: 43.70853, lon: 10.4036, hasResults: False