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Completed

NCT Number: NCT03737435

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

International, multicenter retrospecitve biological study

Completed

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Key information

Conditions

Localized Osteosarcoma

Sex eligibility

All sexes

Study type

Observational

Primary location

SSD Chemioterapia dei tumori dell'apparato locomotore

Bologna, 40136, Italy

About this study

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)

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with primary localized osteosarcoma who received chemotherapy +/- mifamurtide according to ISG-OS2/GEIS-33 trials,
  • Paraffin-embedded tissue tumor (FFPE) blocks from archive available to perform the biological analysis
  • Written informed consent prior to any study-specific analysis and/or data collection

Exclusion criteria

  • Patients with diagnosis different from osteosarcoma

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Treatment and study plan

Primary outcomes

  1. Characterize the immunephenotype in patients with localized osteosarcoma treated with chemotherapy +/- mifamurtide for primary osteosarcoma

    Time frame: 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

  2. Correlate the rate of immune cells, and the level of the PDL-1 checkpoint with event-free survival and overall-survival

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Acronym: Micros

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Nov 9, 2018
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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