Analyzing tumor microenvironment in localized osteosarcoma patients treated with mifamurtide
Tumor Microenvironment in Patients With Localized Osteosarcoma Treated With Mifamurtide: a Translational Study
This study looks at how the treatment with mifamurtide, along with chemotherapy, affects the tumor environment in patients with localized osteosarcoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Bologna) |
| Trial ID | NCT03737435 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze the tumor microenvironment in patients with localized osteosarcoma who have been treated with chemotherapy, with or without mifamurtide. It is an international, multicenter retrospective biological study that utilizes archival biological samples to conduct its analysis. The study focuses on patients who participated in the ISG-OS2 and GEIS-33 protocols, allowing for a comprehensive examination of the effects of treatment on tumor biology.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with primary localized osteosarcoma who have received chemotherapy with or without mifamurtide.
Not a fit: Patients diagnosed with conditions other than osteosarcoma will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the tumor microenvironment that may lead to improved treatment strategies for localized osteosarcoma.
How similar studies have performed: While this study is retrospective and focuses on a specific treatment approach, similar studies analyzing tumor microenvironments have shown promise in understanding cancer biology and treatment responses.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with primary localized osteosarcoma who received chemotherapy +/- mifamurtide according to ISG-OS2/GEIS-33 trials, 2. Paraffin-embedded tissue tumor (FFPE) blocks from archive available to perform the biological analysis 3. Written informed consent prior to any study-specific analysis and/or data collection Exclusion Criteria: 1) Patients with diagnosis different from osteosarcoma -
Where this trial is running
Bologna
- SSD Chemioterapia dei tumori dell'apparato locomotore — Bologna, Italy (Recruiting)
Study contacts
- Study coordinator: Emanuela Palmerini, MD
- Email: emanuela.palmerini@ior.it
- Phone: +390516966199
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.