Tumor Microenvironment in Patients With Localized Osteosarcoma Treated With Mifamurtide: a Translational Study

Recruiting

• Conditions: Localized Osteosarcoma

• Registration Number: NCT03737435
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief Summary

International, multicenter retrospecitve biological study

Detailed Description

International, multicenter retrospecitve biological study that will analyze the tumor micro environment in biological archival samples of patients, who were treated with chemotherapy +/- mifamurtide according the protocols for primary localized osteosarcoma (ISG-OS2 and GEIS-33)

Study Timeline

• Study First Submitted: 2018-11-08
• Study First Submitted QC: 2018-11-08
• Study First Posted: 2018-11-09
• Study Start: 2018-12-12
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-23
• Last Update Posted: 2024-08-27
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Characterize the immunephenotype in patients with localized osteosarcoma treated with chemotherapy +/- mifamurtide for primary osteosarcoma	at baseline (Day0)	A gene expression profile analysis will be performed through NanoString, using the PanCancer Immune Profiling Panel, which includes 770 genes related to the tumor microenvironment. This analysis will be carried out on the NanoString platform, present at the Hemolympopathology Division of the European Institute of Oncology
Correlate the rate of immune cells, and the level of the PDL-1 checkpoint with event-free survival and overall-survival	at baseline (Day0)	For survival analysis the following factors will be correlated with Overall Suvival and Event Free Survival age (pediatric \< 18 years vs adult ≥ 18 years), gender, LDH and phosphatase alkaline (PA) levels at baseline (normal vs high), pathologic response (good: chemotherapy-induced tumor necrosis ≥ 90%; poor: chemotherapy-induced tumor necrosis \< 90%, \[10\]), tumoral miroenvironment components, PD-1 expression on IC, and PD-L1 both on TC and IC., genetic signatures.

Trial Locations

Locations (1)

SSD Chemioterapia dei tumori dell'apparato locomotore; 🇮🇹 Bologna, Italy