Identification of Circulating Biomarkers Associated With... | NCT07685405

Studies
Identification of Circulating Biomarkers Associated With Extracellular Vesicles in Sarcomas

NCT07685405

Sponsor

Istituto Ortopedico Rizzoli

Status

Recruiting

Last Update Posted

Jul 6, 2026Actual

Enrollment

16Estimated

Phase

Not provided

Conditions

Sarcoma, Ewing

Interventions

one blood sample
3 blood samples

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

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 15, 2026Actual

Primary Completion Date

Apr 2028Estimated

Completion Date

Apr 2028Estimated

First Submitted Date

Jun 29, 2026

First Submission Date that Met QC Criteria

Jun 29, 2026

First Posted Date

Jul 6, 2026Actual

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

Jun 29, 2026

Last Update Posted Date

Jul 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study involves blood samples from patients with Ewing's sarcoma to identify circulating biomarkers as a tool for the preclinical validation of innovative therapeutic approaches

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

16Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
oncological subject			Other: 3 blood samples
non-oncological subjects			Other: one blood sample

Interventions

Name	Type	Description	Arm Group Labels	Other Names
one blood sample	Other	non onco	non-oncological subjects
3 blood samples

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
characterisation of circulating biomarkers	search for circulating biomarkers from blood samples taken at three different time points	at baseline (time 0); before surgery; after 6 months from surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria for cancer patients

Male and female patients of any age diagnosed with Ewing sarcoma.
Signed, study-specific informed consent form for the BIOVES study (cancer patients)

Inclusion criteria for non-cancer patients

Male and female patients of legal age without a cancer diagnosis.
Signed, study-specific informed consent form for the BIOVES study (non-cancer patients)

Exclusion Criteria:

Patients who do not meet all inclusion criteria

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The study aims to enroll patients of any gender who are being treated at the Rizzoli Orthopedic Institute in the following departments: Orthopedic and Traumatology Clinic III (with a primary focus on oncology), General and Thoracic Surgery (for both cancer and non-cancer patients), and Osteoncology, Bone and Soft Tissue Sarcomas, and Innovative Therapies (for cancer patients only).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Katia Scotlandi, MSc	Contact	39 051 6366760		katia.scotlandi@ior.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istituto ortopedico Rizzoli Laboratorio di Ricerc Oncologica e Genomica funzioanle	Recruiting	Bologna	BO	40136	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012512	Sarcoma, Ewing

Ancestor Terms

ID	Term
D012516	Osteosarcoma
D018213	Neoplasms, Bone Tissue
D009372	Neoplasms, Connective Tissue
D018204	Neoplasms, Connective and Soft Tissue

Browse Leaves

Not provided

Browse Branches

Not provided