Retro-prospective Observational Study on the Role of the β3 Adrenergic Receptor as a Tumour Biomarker in Paediatric Solid Tumours
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(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
排除标准
- •(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
研究组 & 干预措施
Patients with tumour (age 0-20 years)
Patients affected by Wilms' tumour, Ewing's Sarcoma, Osteosarcoma, Soft tissue sarcomas, Carcinomas, Neuroblastoma age between 0-20 years
干预措施: Analysis of biological sample (Substudy-solid neoplasms) (Other)
Patients with tumour (age 0-75 years)
Patients affected by Ewing's Sarcoma, Neuroblastoma, Paediatric leukaemia, Breast, lung, colon and ovarian cancers between 0-75 years
干预措施: Analysis of biological sample (substudy-leukaemia patients) (Other)
Control Patients group
Patients underwent their diagnostic pathway, which made it possible to exclude the presence of any ongoing pathological process
干预措施: Analysis of peripheral blood (control group) (Other)
结局指标
主要结局
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
时间窗: through study completion, an average of 1 year
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.
Assessment of oxidative stress in peripheral blood samples from enrolled patients
时间窗: through study completion, an average of 1 year
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.
次要结局
- Evaluation of the role of the β3 receptor in apoptosis resistance (substudy)(through study completion, an average of 1 year)
研究者
Annalisa Tondo
Principal Investigator
Meyer Children's Hospital IRCCS