Observing local relapse in patients with high-grade osteosarcoma
An Observational Study of Local Relapse After High Grade Osteosarcoma
Istituto Ortopedico Rizzoli · NCT06017518
This study looks at patients with high-grade osteosarcoma who had a local relapse after treatment to see what patterns and outcomes are common.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli (other) |
| Locations | 2 sites (Bologna, BO and 1 other locations) |
| Trial ID | NCT06017518 on ClinicalTrials.gov |
What this trial studies
This multicenter observational study aims to analyze cases of local relapse in patients diagnosed with high-grade osteosarcoma. It includes both retrospective data from January 1980 and prospective data from new cases at participating sites. The study will focus on patients who experienced local relapse as their first recurrence event after treatment, including those with synchronous lung metastases. The goal is to gather comprehensive data to better understand the patterns and outcomes of local relapse in this patient population.
Who should consider this trial
Good fit: Ideal candidates are patients who have experienced local relapse after treatment for localized high-grade osteosarcoma, regardless of age.
Not a fit: Patients who have had local relapse after more than three months of metastatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the management and treatment of local relapse in high-grade osteosarcoma, potentially improving patient outcomes.
How similar studies have performed: While there may be studies on osteosarcoma, this specific observational approach focusing on local relapse is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bologna, BO and 1 other locations
- IRCCS Istituto Ortopedico Rizzoli — Bologna, BO, Italy (RECRUITING)
- Azienda Ospedaliero-Universitaria Pisana — Pisa, PI, Italy (RECRUITING)
Study contacts
- Study coordinator: Emanuela Palmerini, MD
- Email: emanuela.palmerini@ior.it
- Phone: 051/6366
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Osteosarcoma