Clinical trial NCT06312150: Role of Tumoral Biomarker B3 Adrenergic Receptor in Paediatric Solid Tumours
Official title: Retro-prospective Observational Study on the Role of the β3 Adrenergic Receptor as a Tumour Biomarker in Paediatric Solid Tumours
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tumor
Lead sponsor: Meyer Children's Hospital IRCCS
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: through study completion, an average of 1 year
measure: Assessment of oxidative stress in peripheral blood samples from enrolled patients
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Evaluation of the role of the β3 receptor in apoptosis resistance (substudy)
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Arezzo
country: Italy
facility: Ospedale San Donato di Arezzo
city: Florence
country: Italy
facility: Meyer Children's Hospital IRCCS
city: Pisa
country: Italy
facility: Azienda Ospedaliera Pisana
Study officials:
References: