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Trial Title:
Role of Tumoral Biomarker B3 Adrenergic Receptor in Paediatric Solid Tumours
NCT ID:
NCT06312150
Condition:
Tumor
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Analysis of peripheral blood (control group)
Description:
Peripheral blood sample will be acquired in excess to the last scheduled control sample
according to clinical practice.
Arm group label:
Control Patients group
Intervention type:
Other
Intervention name:
Analysis of biological sample (Substudy-solid neoplasms)
Description:
peripheral blood sample, bone marrow aspirate and fresh or paraffin biopsia tissutale
will be collected for the substudy
Arm group label:
Patients with tumour (age 0-20 years)
Intervention type:
Other
Intervention name:
Analysis of biological sample (substudy-leukaemia patients)
Description:
sample of peripheral blood and bone marrow blood for the substudy, derived from
paediatric or young adult leukaemia patients
Arm group label:
Patients with tumour (age 0-75 years)
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.
Criteria for 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
Gender:
All
Minimum age:
1 Day
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Ospedale San Donato di Arezzo
Address:
City:
Arezzo
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Carlo Milandri
Email:
carlo.milandri@uslsudest.toscana.it
Facility:
Name:
Meyer Children's Hospital IRCCS
Address:
City:
Florence
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Annalisa Tondo
Phone:
0555662489
Email:
annalisa.tondo@meyer.it
Facility:
Name:
Azienda Ospedaliera Pisana
Address:
City:
Pisa
Country:
Italy
Status:
Active, not recruiting
Start date:
December 17, 2019
Completion date:
December 2025
Lead sponsor:
Agency:
Meyer Children's Hospital IRCCS
Agency class:
Other
Source:
Meyer Children's Hospital IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06312150