TumorNCT06312150
Role of Tumoral Biomarker B3 Adrenergic Receptor in Paediatric Solid Tumours
A study testing Analysis of biological sample (Substudy-solid neoplasms) and Analysis of biological sample (substudy-leukaemia patients) in people with Tumor, run by Meyer Children's Hospital IRCCS at 3 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Tumor
- What is being tested?
- Analysis of biological sample (Substudy-solid neoplasms) and Analysis of biological sample (substudy-leukaemia patients)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesItaly
- Study dates
- 17 Dec 2019to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
- Diagnosis of Ewing's Sarcoma, Neuroblastoma, Paediatric leukaemia, Tumours of the breast, lung, colon and ovary
Show all 16Show fewer
- 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
- 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
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites, 2 recruiting
- Not yet recruiting
Ospedale San Donato di Arezzo
Arezzo
Carlo Milandri, carlo.milandri@uslsudest.toscana.it
- Recruiting
Meyer Children's Hospital IRCCS
Florence
Annalisa Tondo, 0555662489, annalisa.tondo@meyer.it
- Active, not recruiting
Azienda Ospedaliera Pisana
Pisa
About this study
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.
- Conditions
- Tumor
- Being tested
- Analysis of peripheral blood (control group), Analysis of biological sample (Substudy-solid neoplasms), Analysis of biological sample (substudy-leukaemia patients)
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analysis of peripheral blood (control group)Other
Peripheral blood sample will be acquired in excess to the last scheduled control sample according to clinical practice.
Analysis of biological sample (Substudy-solid neoplasms)Other
peripheral blood sample, bone marrow aspirate and fresh or paraffin biopsia tissutale will be collected for the substudy
Analysis of biological sample (substudy-leukaemia patients)Other
sample of peripheral blood and bone marrow blood for the substudy, derived from paediatric or young adult leukaemia patients
| Study group | Role | What they receive |
|---|---|---|
| Patients with tumour (age 0-20 years) | Other | Patients affected by Wilms' tumour, Ewing's Sarcoma, Osteosarcoma, Soft tissue sarcomas, Carcinomas, Neuroblastoma age between 0-20 years Receives: Other: Analysis of biological sample (Substudy-solid neoplasms) |
| Patients with tumour (age 0-75 years) | Other | Patients affected by Ewing's Sarcoma, Neuroblastoma, Paediatric leukaemia, Breast, lung, colon and ovarian cancers between 0-75 years Receives: Other: Analysis of biological sample (substudy-leukaemia patients) |
| Control Patients group | Other | Patients underwent their diagnostic pathway, which made it possible to exclude the presence of any ongoing pathological process Receives: Other: Analysis of peripheral blood (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: through study completion, an average of 1 year
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Evaluation of the role of the β3 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).
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start17 Dec 2019
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TumorStudies of the same condition, open and under way.
- More trials run by Meyer Children's Hospital IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meyer Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annalisa Tondo, Meyer Children's Hospital IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312150
- Sponsor's protocol ID
- BETA 3 2019
- Status last verified
- Mar 2024
- First submitted
- 8 Mar 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retro-prospective Observational Study on the Role of the β3 Adrenergic Receptor as a Tumour Biomarker in Paediatric Solid Tumours
- ClinicalTrials.gov ID
- NCT06312150
- Acronym / sponsor ID
- BETA 3 2019
- Conditions
- Tumor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Meyer Children's Hospital IRCCSUniversity, hospital or other
- Study start
- 17 Dec 2019 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with tumour (age 0-20 years) | Other | Other: Analysis of biological sample (Substudy-solid neoplasms)Patients affected by Wilms' tumour, Ewing's Sarcoma, Osteosarcoma, Soft tissue sarcomas, Carcinomas, Neuroblastoma age between 0-20 years |
| Patients with tumour (age 0-75 years) | Other | Other: Analysis of biological sample (substudy-leukaemia patients)Patients affected by Ewing's Sarcoma, Neuroblastoma, Paediatric leukaemia, Breast, lung, colon and ovarian cancers between 0-75 years |
| Control Patients group | Other | Other: Analysis of peripheral blood (control group)Patients underwent their diagnostic pathway, which made it possible to exclude the presence of any ongoing pathological process |
Who may qualify
- Ages
- 1 day to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Analysis of peripheral blood (control group)Peripheral blood sample will be acquired in excess to the last scheduled control sample according to clinical practice. | Other | Control Patients group |
| Analysis of biological sample (Substudy-solid neoplasms)peripheral blood sample, bone marrow aspirate and fresh or paraffin biopsia tissutale will be collected for the substudy | Other | Patients with tumour (age 0-20 years) |
| Analysis of biological sample (substudy-leukaemia patients)sample of peripheral blood and bone marrow blood for the substudy, derived from paediatric or young adult leukaemia patients | Other | Patients with tumour (age 0-75 years) |
Primary outcome
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
Time frame: 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
Time frame: 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.
1 secondary outcome
Evaluation of the role of the β3 receptor in apoptosis resistance (substudy)
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Analysis of biological sample (Substudy-solid neoplasms) and Analysis of biological sample (substudy-leukaemia patients) in people with Tumor, run by Meyer Children's Hospital IRCCS at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annalisa Tondo (0555662489, annalisa.tondo@meyer.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2024.