Clinical trial Recruiting at 15 sites Observational Ages Any age to 40

Observational study of localized osteosarcoma characteristics and treatments

Official title: Multicenter Observational Study on the Treatment of Patients With Localized Osteosarcoma

Run by Italian Sarcoma Group · NCT04890067 · Data updated 2026-11-12

This study is looking at the characteristics and treatments of people with localized osteosarcoma to see how well current therapies work and to help improve future care.

Quick facts

Study typeObservational
AgesAny age to 40 Years
SexAll
Enrollment120 (estimated)
SponsorItalian Sarcoma Group
Research network
Drugs / interventionschemotherapy, methotrexate
Locations16 sites (Aviano, Pordenone and 15 other locations)
StatusRecruiting
StartedJuly 30, 2021
Main results expectedSeptember 30, 2029
Study endsDecember 30, 2029
Registry record updatedNovember 3, 2026
Trial IDNCT04890067 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are individuals aged 40 years or younger diagnosed with high-grade localized osteosarcoma.

Probably not a fit

Patients with metastatic osteosarcoma or those with specific types of osteosarcoma such as periosteal or parosteal may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to collect demographic, clinical, surgical, pathological, and molecular data from patients diagnosed with localized osteosarcoma. It focuses on individuals treated according to the AIEOP/Italian Sarcoma Group OS 2021 guidelines, which include a combination of chemotherapy and surgical intervention. The study will gather information on treatment outcomes and characteristics to enhance understanding of this rare disease. By documenting these factors, the study seeks to improve future treatment protocols for localized osteosarcoma.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies and outcomes for patients with localized osteosarcoma.

How similar studies have gone: While there have been studies on osteosarcoma treatment, this observational approach focusing on localized cases and comprehensive data collection is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Diagnosis of high grade OS of the extremities
* Age at diagnosis ≤ 40 years at the time of diagnosis
* Localized disease (skip metastases are allowed)
* Adequate organ function according the AIEOP/ISG OS 2021 recommendation
* Patients or parents oe guardians of minors who have given their written informed consent to participate in the study

Exclusion Criteria:

* Presence of metastases
* Diagnosis of periosteal OS, of parosteal OS or secondary OS
* Any medical condition which can not allowed the use of the treatments recommended by AIEOP/ISG OS 2021

Where it's running

  • Centro di Riferimento Oncologico - Unit of Medical Oncology
    Aviano, Pordenone, Italy
    Recruiting
  • Sandra Aliberti
    Candiolo, Torino, Italy
    Recruiting
  • IRCCS materno infantile Burlo Garofolo
    Trieste, T, Italy
    Recruiting
  • Azienda Ospedaliero Universitaria Consorziale Policlinico - Bari
    Bari, Italy
    Recruiting
  • IRCCS Istituto ortopedico Rizzoli
    Bologna, Italy
    Recruiting
  • A.O. Universitaria Policlinico S. Orsola Malpighi di Bologna
    Bologna, Italy
    Recruiting
Show 10 more locations
  • AUO Policnico G. Rodolico San Marco
    Catania, Italy
    Recruiting
  • A.O. Universitaria Meyer
    Florence, Italy
    Recruiting
  • Istituto Giannina Gaslini
    Genova, Italy
    Recruiting
  • Fondazione IRCCS INT Milano SC Pediatria Oncologica
    Milan, Italy
    Recruiting
  • FONDAZIONE IRCCS Istituto Nazionale dei Tumori
    Milan, Italy
    Recruiting
  • Azienda Ospedaliera di Padova UOC Oncoematologia Pediatrica
    Padova, Italy
    Recruiting
  • ARNAS P. O. "Civico e Benfratelli"
    Palermo, Italy
    Recruiting
  • Azienda Ospedaliero-Universitaria Pisana
    Pisa, Italy
    Recruiting
  • Istituti Fisioterapici Ospitalieri di Roma
    Roma, Italy
    Recruiting
  • Ospedale Pediatrico Bambin Gesu'
    Roma, Italy
    Not yet recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.