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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03737435

Acronym

Micros

Enrollment

Registered

2018-11-09

Start date

2018-12-12

Completion date

2024-10-25

Last updated

2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Localized Osteosarcoma

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)

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

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 \-

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Italy

Outcome results