Role of Tumoral Biomarker B3 Adrenergic Receptor in Paediatric Solid Tumours

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-17

Study Completion Date

2025-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Patients with tumour (age 0-20 years)

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

Group Type OTHER

Analysis of biological sample (Substudy-solid neoplasms)

Intervention Type OTHER

peripheral blood sample, bone marrow aspirate and fresh or paraffin biopsia tissutale will be collected for the substudy

Patients with tumour (age 0-75 years)

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

Group Type OTHER

Analysis of biological sample (substudy-leukaemia patients)

Intervention Type OTHER

sample of peripheral blood and bone marrow blood for the substudy, derived from paediatric or young adult leukaemia patients

Control Patients group

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

Group Type OTHER

Analysis of peripheral blood (control group)

Intervention Type OTHER

Peripheral blood sample will be acquired in excess to the last scheduled control sample according to clinical practice.

Interventions

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Analysis of peripheral blood (control group)

Peripheral blood sample will be acquired in excess to the last scheduled control sample according to clinical practice.

Intervention Type OTHER

Analysis of biological sample (Substudy-solid neoplasms)

peripheral blood sample, bone marrow aspirate and fresh or paraffin biopsia tissutale will be collected for the substudy

Intervention Type OTHER

Analysis of biological sample (substudy-leukaemia patients)

sample of peripheral blood and bone marrow blood for the substudy, derived from paediatric or young adult leukaemia patients

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

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

Exclusion Criteria

* 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

Minimum Eligible Age

1 Day

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes