CompletedNot Applicable

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

Italy80 participantsStarted 2018-12-12

Plain-language summary

International, multicenter retrospecitve biological study

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: at baseline (Day0)

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

Timeframe: at baseline (Day0)

Trial details

NCT IDNCT03737435

SponsorIstituto Ortopedico Rizzoli

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-10-25

View on ClinicalTrials.gov More Localized Osteosarcoma trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: at baseline (Day0)

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

Timeframe: at baseline (Day0)