Retro-prospective Observational Study on the Role of the β3 Adrenergic Receptor as a Tumour Biomarker in Paediatric Solid Tumours
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Tumor
- Sponsor
- Meyer Children's Hospital IRCCS
- Enrollment
- 60
- Locations
- 3
- Primary Endpoint
- 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
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Annalisa Tondo
Principal Investigator
Meyer Children's Hospital IRCCS
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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
Time Frame: 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
Time Frame: 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 Outcomes
- Evaluation of the role of the β3 receptor in apoptosis resistance (substudy)(through study completion, an average of 1 year)