Role of Tumoral Biomarker B3 Adrenergic Receptor in Paediatric Solid Tumours
- Conditions
- Tumor
- Interventions
- Other: Analysis of peripheral blood (control group)Other: Analysis of biological sample (Substudy-solid neoplasms)Other: Analysis of biological sample (substudy-leukaemia patients)
- Registration Number
- NCT06312150
- Lead Sponsor
- Meyer Children's Hospital IRCCS
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Patients group Analysis of peripheral blood (control group) Patients underwent their diagnostic pathway, which made it possible to exclude the presence of any ongoing pathological process Patients with tumour (age 0-20 years) Analysis of biological sample (Substudy-solid neoplasms) Patients affected by Wilms' tumour, Ewing's Sarcoma, Osteosarcoma, Soft tissue sarcomas, Carcinomas, Neuroblastoma age between 0-20 years Patients with tumour (age 0-75 years) Analysis of biological sample (substudy-leukaemia patients) Patients affected by Ewing's Sarcoma, Neuroblastoma, Paediatric leukaemia, Breast, lung, colon and ovarian cancers between 0-75 years
- Primary Outcome Measures
Name Time Method 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 through study completion, an average of 1 year Cytofluorimetric data following labelling with specific fluorescent antibodies and after specific gating strategy, specific for each tumour or healthy cell, will be reported as a percentage (%), mean or median expression on the viable population of cells expressing the receptor. Data will be acquired at the MacsQuant Miltenyi Biotech cytofluorometer and analysed withFlowLogic® software programme.
Assessment of oxidative stress in peripheral blood samples from enrolled patients through study completion, an average of 1 year Oxidative stress in the peripheral blood of patients enrolled in the main study will be assessed and healthy subjects, through the use of the Callegari instrument by measuring the amount of free radicals and antioxidants in the sample under analysis using specific detection kits.
- Secondary Outcome Measures
Name Time Method Evaluation of the role of the β3 receptor in apoptosis resistance (substudy) through study completion, an average of 1 year Cells properly isolated and resuspended in PBS (phosphate buffered saline) will be incubated at room temperature with specific antibodies for Annessin V and Propidium Iodide (PI) compound and subsequently evaluated by flow cytometry (FACS).
Trial Locations
- Locations (3)
Ospedale San Donato di Arezzo
🇮🇹Arezzo, Italy
Meyer Children's Hospital IRCCS
🇮🇹Florence, Italy
Azienda Ospedaliera Pisana
🇮🇹Pisa, Italy