Evaluating the role of a specific receptor in childhood solid tumors

Retro-prospective Observational Study on the Role of the β3 Adrenergic Receptor as a Tumour Biomarker in Paediatric Solid Tumours

This study is testing if a specific receptor found in the blood of kids with solid tumors can help doctors understand how aggressive the tumors are and find new treatment options.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 1 Day to 75 Years
• Sex: All
• Sponsor: Meyer Children's Hospital IRCCS (Academic / other)
• Locations: 3 sites (Arezzo and 2 other locations)
• Trial ID: NCT06312150 on ClinicalTrials.gov

What this trial studies

This study aims to investigate the expression of the β3 adrenergic receptor in the peripheral blood of pediatric patients diagnosed with solid tumors, comparing their results to a healthy control group. It involves collecting biological samples, including peripheral blood and bone marrow, from patients diagnosed with various types of tumors such as Wilms' tumor, Ewing's sarcoma, and neuroblastoma. The study seeks to identify potential prognostic factors or therapeutic targets related to tumor aggressiveness and progression. The research is conducted across multiple centers to gather a diverse set of biological samples for analysis.

Who should consider this trial

Good fit: Ideal candidates include pediatric patients aged 0 to 20 years diagnosed with specific solid tumors or leukemia.

Not a fit: Patients with tumors diagnosed before 2015 or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved prognostic assessments and targeted therapies for childhood cancers.

How similar studies have performed: While the role of β-adrenergic receptors in tumor progression has been explored, this specific approach in pediatric solid tumors is relatively novel.

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

Where this trial is running

Arezzo and 2 other locations

• 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)

Study contacts

• Study coordinator: Annalisa Tondo

Conditions Tumor