Role of Tumoral Biomarker B3 Adrenergic Receptor in Paediatric Solid Tumours

Meyer Children's Hospital IRCCS

Status: Enrolling

Conditions: Tumor

Treatments: Other: Analysis of biological sample (substudy-leukaemia patients); Other: Analysis of peripheral blood (control group); Other: Analysis of biological sample (Substudy-solid neoplasms)

Study type: Interventional

Funder types: Other

Identifiers

NCT06312150

BETA 3 2019

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 1 day to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (principal study):

• Diagnoses, received after the year 2015 (Wilms' tumour, Ewing's Sarcoma, Osteosarcoma, Soft tissue sarcomas, Carcinomas, Neuroblastoma)
• Informed consent signed by parents or the patient if over 18 years of age
• Planned follow-up for 5 years
• Availability of a sufficient peripheral blood sample for analysis at onset.
• Age between 0 and 20 years

Inclusion Criteria (substudy):

• Diagnosis of Ewing's Sarcoma, Neuroblastoma, Paediatric leukaemia, Tumours of the breast, lung, colon and ovary
• Informed consent signed by parents or by the patient if 18 years of age19
• Planned follow-up for 5 years
• Availability of biological samples (peripheral blood, bone marrow blood, biopsy at onset) sufficient for the study investigations.
• Age between 0 and 20 years for paediatric patients referred to CROP Centres - Florence and Pisa
• Age between 19 and 75 years for adult patients attending the San Donato Hospital in Arezzo

Inclusion criteria (control group)

• Age between 0 and 30 years
• No evidence of acute or chronic infectious/inflammatory disease

Exclusion Criteria (for every partecipants to the principal study and substudy):

• Patients with HIV, HCV and HBV seropositivity (HBSAg) due to biohazard and bias related to patients' immunological status that could influence gene expression and tumour behaviour.
• Pregnant or lactating patients as the altered hormonal panel is a factor disturbing the expression of β3ARs

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

Patients with tumour (age 0-20 years)

Other group

Description:

Patients affected by Wilms' tumour, Ewing's Sarcoma, Osteosarcoma, Soft tissue sarcomas, Carcinomas, Neuroblastoma age between 0-20 years

Treatment:

Other: Analysis of biological sample (Substudy-solid neoplasms)

Patients with tumour (age 0-75 years)

Other group

Description:

Patients affected by Ewing's Sarcoma, Neuroblastoma, Paediatric leukaemia, Breast, lung, colon and ovarian cancers between 0-75 years

Treatment:

Other: Analysis of biological sample (substudy-leukaemia patients)

Control Patients group

Other group

Description:

Patients underwent their diagnostic pathway, which made it possible to exclude the presence of any ongoing pathological process

Treatment:

Other: Analysis of peripheral blood (control group)