An Observational Study of Local Relapse After High Grade... | NCT06017518

Studies
An Observational Study of Local Relapse After High Grade Osteosarcoma

NCT06017518

Sponsor

Istituto Ortopedico Rizzoli

Status

Recruiting

Last Update Posted

Sep 22, 2025Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Osteosarcoma

Interventions

Not provided

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

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

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

Jun 13, 2022Actual

Primary Completion Date

Jun 30, 2026Estimated

Completion Date

Jun 30, 2026Estimated

First Submitted Date

Aug 24, 2023

First Submission Date that Met QC Criteria

Aug 24, 2023

First Posted Date

Aug 30, 2023Actual

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

Sep 19, 2025

Last Update Posted Date

Sep 22, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

multicenter retrospective and prospective study in patients with high-grade osteosarcoma

Detailed Description

This is a multicenter retrospective and prospective study that will analyze all cases with of diagnosis of local relapse in high-grade osteosarcoma from 01 January 1980 and all new cases referring to each participant site.

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

150Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
post local relapse survival	the aim of the study is to analyse the factors influencing post local relapse survival	24 months follow up

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who experienced LR as first event of recurrence after treatment for localized high-grade osteosarcoma of bone, including cases with synchronous lung metastases
Adequate patient compliance to follow-up visits
Written informed consent prior to any study-specific analysis and/or data collection
No age limits

Exclusion Criteria:

Cases of LR demonstrated after > 3 months after metastatic disease
Impossibility to ensure adequate compliance

Accepts Healthy Volunteers

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

Patients who experienced local relapse as first event of recurrence after treatment for localized high-grade osteosarcoma of bone, including cases with synchronous lung metastases

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Emanuela Palmerini, MD	Contact	051/6366	668	emanuela.palmerini@ior.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IRCCS Istituto Ortopedico Rizzoli	Recruiting	Bologna	BO	40136	Italy

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 10, 2022	Aug 24, 2023	Prot_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D012516	Osteosarcoma

Ancestor Terms

ID	Term
D018213	Neoplasms, Bone Tissue
D009372	Neoplasms, Connective Tissue
D018204	Neoplasms, Connective and Soft Tissue
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided