Β3-adrenoreceptor As Prognostic Marker in Neuroblastoma a... | NCT06851221

Studies
Β3-adrenoreceptor As Prognostic Marker in Neuroblastoma and Ewing Sarcoma

NCT06851221

Sponsor

Meyer Children's Hospital IRCCS

Status

Completed

Last Update Posted

Feb 28, 2025Actual

Enrollment

95Actual

Phase

Not Applicable

Conditions

Neuroblastoma
Ewing Sarcoma

Interventions

beta3 expression

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 5, 2020Actual

Primary Completion Date

Mar 5, 2024Actual

Completion Date

Mar 5, 2024Actual

First Submitted Date

Feb 21, 2025

First Submission Date that Met QC Criteria

Feb 26, 2025

First Posted Date

Feb 28, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2025

Last Update Posted Date

Feb 28, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maura Calvani, Head of Traslational oncoematology laboratory, Meyer Children's Hospital IRCCSPrincipal Investigator

Lead Sponsor

Meyer Children's Hospital IRCCSOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study on biological samples of patients affected by neuroblastoma and Ewing sarcoma aims at validating the beta3-adrenoreceptor as prognostic biomarker.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

95Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
biological samples analysis	Other		Diagnostic Test: beta3 expression

Interventions

Name	Type	Description	Arm Group Labels	Other Names
beta3 expression	Diagnostic Test	the samples leftover from the standard diagnostic procedures will be analyzed for the expression of the beta3-adrenoreceptor	biological samples analysis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
expression of beta3-adrenoreceptor		from enrollment to the performance of the analysis that can take up to 6 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosis of Ewing sarcoma or neuroblastoma

Exclusion Criteria:

sieropositivity

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Laboratorio traslazionale in oncoematologia		Florence	Italy	50139	Italy

Condition Browse Module

MeSH Terms

ID	Term
D009447	Neuroblastoma
D012512	Sarcoma, Ewing

Ancestor Terms

ID	Term
D018241	Neuroectodermal Tumors, Primitive, Peripheral
D018242	Neuroectodermal Tumors, Primitive
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors

Browse Leaves

Not provided

Browse Branches

Not provided