To hear about similar clinical trials, please enter your email below

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

Login to your account

Did you forget your password?