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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with tumour (age 0-20 years) | Other | Patients affected by Wilms' tumour, Ewing's Sarcoma, Osteosarcoma, Soft tissue sarcomas, Carcinomas, Neuroblastoma age between 0-20 years |
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| Patients with tumour (age 0-75 years) | Other | Patients affected by Ewing's Sarcoma, Neuroblastoma, Paediatric leukaemia, Breast, lung, colon and ovarian cancers between 0-75 years |
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| Control Patients group | Other | Patients underwent their diagnostic pathway, which made it possible to exclude the presence of any ongoing pathological process |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Analysis of peripheral blood (control group) | Other | Peripheral blood sample will be acquired in excess to the last scheduled control sample according to clinical practice. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | through study completion, an average of 1 year |
| Assessment of oxidative stress in peripheral blood samples from enrolled patients | 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. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the role of the β3 receptor in apoptosis resistance (substudy) | 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). | through study completion, an average of 1 year |
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Inclusion Criteria (principal study):
Inclusion Criteria (substudy):
Inclusion criteria (control group)
Exclusion Criteria (for every partecipants to the principal study and substudy):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annalisa Tondo | Contact | 0555662489 | annalisa.tondo@meyer.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale San Donato di Arezzo | Not yet recruiting | Arezzo | Italy |
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| Analysis of biological sample (Substudy-solid neoplasms) | Other | peripheral blood sample, bone marrow aspirate and fresh or paraffin biopsia tissutale will be collected for the substudy |
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| Analysis of biological sample (substudy-leukaemia patients) | Other | sample of peripheral blood and bone marrow blood for the substudy, derived from paediatric or young adult leukaemia patients |
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| Meyer Children's Hospital IRCCS | Recruiting | Florence | Italy |
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| Azienda Ospedaliera Pisana | Active, not recruiting | Pisa | Italy |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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