Role of Tumoral Biomarker B3 Adrenergic Receptor in Paediatric Solid Tumours

Last updated: March 15, 2024
Sponsor: Meyer Children's Hospital IRCCS
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer

Carcinoma

Treatment

Analysis of peripheral blood (control group)

Analysis of biological sample (Substudy-solid neoplasms)

Analysis of biological sample (substudy-leukaemia patients)

Clinical Study ID

NCT06312150
BETA 3 2019
  • Ages 1-75
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

Total Participants: 60
Treatment Group(s): 3
Primary Treatment: Analysis of peripheral blood (control group)
Phase:
Study Start date:
December 17, 2019
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Ospedale San Donato di Arezzo

    Arezzo,
    Italy

    Site Not Available

  • Meyer Children's Hospital IRCCS

    Florence,
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Pisana

    Pisa,
    Italy

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.