Role of Tumoral Biomarker B3 Adrenergic Receptor in Paediatric Solid Tumours

NCT06312150 | Recruiting

• 1 other identifier: BETA 3 2019
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Tumor

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Evaluation of the role of the β3 receptor in apoptosis resistance (substudy)

  through study completion, an average of 1 year

Study Arms (3)

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

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

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

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

Control Patients group

OTHER

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

Other: Analysis of peripheral blood (control group)

Interventions

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.

Control Patients group

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

Patients with tumour (age 0-20 years)

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

Patients with tumour (age 0-75 years)

Eligibility Criteria

• Age: 1 Day - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Meyer Children's Hospital IRCCS: lead

Study Sites (3)

Ospedale San Donato di Arezzo

Arezzo, Italy

NOT YET RECRUITING

Meyer Children's Hospital IRCCS

Florence, Italy

RECRUITING

Azienda Ospedaliera Pisana

Pisa, Italy

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Annalisa Tondo

CONTACT

0555662489; annalisa.tondo@meyer.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 15, 2024
• Study Start: December 17, 2019
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 18, 2024

Record last verified: 2024-03

Locations

IT (3)