Tumor Clinical Trial
Official title:
Retro-prospective Observational Study on the Role of the β3 Adrenergic Receptor as a Tumour Biomarker in Paediatric Solid Tumours
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 2025 |
Est. primary completion date | September 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Day to 75 Years |
Eligibility | 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 ß3ARs |
Country | Name | City | State |
---|---|---|---|
Italy | Ospedale San Donato di Arezzo | Arezzo | |
Italy | Meyer Children's Hospital IRCCS | Florence | |
Italy | Azienda Ospedaliera Pisana | Pisa |
Lead Sponsor | Collaborator |
---|---|
Meyer Children's Hospital IRCCS |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of ß3 receptor expression in the peripheral blood, bone marrow and bioptic samples of patients with solid tumours compared to a healthy control group | Cytofluorimetric data following labelling with specific fluorescent antibodies and after specific gating strategy, specific for each tumour or healthy cell, will be reported as a percentage (%), mean or median expression on the viable population of cells expressing the receptor. Data will be acquired at the MacsQuant Miltenyi Biotech cytofluorometer and analysed withFlowLogic® software programme. | through study completion, an average of 1 year | |
Primary | Assessment of oxidative stress in peripheral blood samples from enrolled patients | Oxidative stress in the peripheral blood of patients enrolled in the main study will be assessed and healthy subjects, through the use of the Callegari instrument by measuring the amount of free radicals and antioxidants in the sample under analysis using specific detection kits. | through study completion, an average of 1 year | |
Secondary | Evaluation of the role of the ß3 receptor in apoptosis resistance (substudy) | Cells properly isolated and resuspended in PBS (phosphate buffered saline) will be incubated at room temperature with specific antibodies for Annessin V and Propidium Iodide (PI) compound and subsequently evaluated by flow cytometry (FACS). | through study completion, an average of 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04848376 -
Post-Market Clinical Follow-up Study of A-SPINE's Products
|
||
Active, not recruiting |
NCT05470283 -
Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma
|
Phase 1 | |
Completed |
NCT05041920 -
A Drug-drug Interaction Study of Famitinib Malate With a Proton Pump Inhibitor in Healthy Adult Subjects
|
Phase 1 | |
Recruiting |
NCT04430361 -
the Efficacy and Safety of 5-HT3 Receptor Antagonist, Dexamethasone or Megestrol Acetate Dispersible Tablets in the Control of Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy
|
Phase 2 | |
Not yet recruiting |
NCT05443854 -
Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01)
|
Phase 3 | |
Not yet recruiting |
NCT05549557 -
IMM40H Phase I Dose Escalation and Expansion
|
Phase 1 | |
Completed |
NCT01946555 -
Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain
|
N/A | |
Terminated |
NCT01846429 -
Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain
|
Phase 1 | |
Recruiting |
NCT01093079 -
Laparoscopic Versus Open Partial Nephrectomy - Surgical and Oncological Outcomes
|
N/A | |
Recruiting |
NCT01387971 -
Using Impression Cytology to Observe the Cytological Changes of Ocular Surface Cells in Various Ocular Surface Disorders
|
N/A | |
Recruiting |
NCT00690261 -
The Impact of M1/M2 Tumor Associated Macrophage (TAM) Polarization on Cancer Progression and Prognosis Prediction
|
N/A | |
Completed |
NCT00561795 -
Feasibility Study of Pazopanib in Combination With Chemotherapy in Gynaecological Tumors
|
Phase 2 | |
Completed |
NCT00413322 -
Study of PXD101 Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT00152659 -
Developing Criteria for Cortical Resections
|
||
Completed |
NCT00777751 -
Radiation Therapy and Cardiac Enzymes
|
N/A | |
Not yet recruiting |
NCT06109896 -
Clinical Stories and Psychological Experiences of Cancer Patients
|
||
Not yet recruiting |
NCT05879146 -
Evaluation of the Response and Non-response of Nirogacestat in Desmoid Tumors- Clinical Study
|
Phase 2 | |
Recruiting |
NCT02810405 -
Collection of Tissue Blocks or Slides From Patients With Cancer
|
||
Recruiting |
NCT01867268 -
Effect of Acetazolamide & Position in CSF Leakage and Collection and Wound Dehiscence
|
Phase 2 | |
Terminated |
NCT01720745 -
Comparison of "Wet Suction" Technique to Contemporary "Dry Suction" Technique Using a 22 Gauge Needle for EUS FNA
|