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NCT06017518 Clinical Trial

An Observational Study of Local Relapse After High Grade Osteosarcoma

Osteosarcoma Clinical Trial

— OSTEO LR  

Official title:
An Observational Study of Local Relapse After High Grade Osteosarcoma

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06017518
Other study ID # OSTEO LR
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 13, 2022
Est. completion date June 30, 2026

Study information
Verified date August 2023
Source Istituto Ortopedico Rizzoli
Contact Emanuela Palmerini, MD
Phone 051/6366
Email emanuela.palmerini@ior.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date June 30, 2026
Est. primary completion date June 30, 2026
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy IRCCS Istituto Ortopedico Rizzoli Bologna BO
Italy Azienda Ospedaliero-Universitaria Pisana Pisa PI

Sponsors (1)
Lead Sponsor Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary post local relapse survival the aim of the study is to analyse the factors influencing post local relapse survival 24 months follow up
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