Observational Study in Localized Osteosarcoma

NCT04890067 | Recruiting

• 1 other identifier: AIEOP/ISGOS2 Oss
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 16

Brief Summary

Observational prospective trial aimed to collect the collect demographic, clinical, surgical, pathological and molecular characteristics and treatment from patients affected by localized OsteoSarcoma (OS) treated according the AIEOP/Italian Sarcoma Group (ISG) OS 2021

Conditions

Localized Osteosarcoma

Keywords

Osteosarcoma

Outcome Measures

Primary Outcomes (1)

• 5 years Event Free Survival (EFS)

  Onset of any event (an event is the defined as disease recurrence, death for disease or any other cause)

  5 years

Secondary Outcomes (2)

• Overall Survival (OS)

  at 5 years

• Adverse events related to the treatments

  Every 3 weeks (Week 3, week 6, week 9, week 12, ...) up to 36 months

Study Arms (1)

Localized Osteosarcoma

This cohort include patients affected by localized Osteosarcoma, referred to participating Institutions.

Other: Treatment of Osteosarcoma according the AIEOP/ISG OS 2021 recommendations (includes drugs, surgery, radiotherapy or any other received treatments)

Interventions

Treatment of Osteosarcoma according the AIEOP/ISG OS 2021 recommendations (includes drugs, surgery, radiotherapy or any other received treatments) OTHER

This observational study collects all the treatments received by the patients according according the AIEOP/ISG OS 2021 and therefore includes drug/biological/surgical/ radiotherapy and any other applicable treatments

Localized Osteosarcoma

Eligibility Criteria

• Age: Up to 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients with localized high grade ostesarcoma of the extremities

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Italian Sarcoma Group: lead
• Associazione Italiana Ematologia Oncologia Pediatrica: collaborator

Study Sites (16)

Centro di Riferimento Oncologico - Unit of Medical Oncology

Aviano, Pordenone, 33081, Italy

RECRUITING

Sandra Aliberti

Candiolo, Torino, 10060, Italy

RECRUITING

IRCCS materno infantile Burlo Garofolo

Trieste, T, 34137, Italy

RECRUITING

Azienda Ospedaliero Universitaria Consorziale Policlinico - Bari

Bari, 70124, Italy

RECRUITING

IRCCS Istituto ortopedico Rizzoli

Bologna, 40136, Italy

RECRUITING

A.O. Universitaria Policlinico S. Orsola Malpighi di Bologna

Bologna, 40138, Italy

RECRUITING

AUO Policnico G. Rodolico San Marco

Catania, 95123, Italy

RECRUITING

A.O. Universitaria Meyer

Florence, 50139, 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

Padua, Italy

RECRUITING

ARNAS P. O. "Civico e Benfratelli"

Palermo, 90127, Italy

RECRUITING

Azienda Ospedaliero-Universitaria Pisana

Pisa, 56126, Italy

RECRUITING

Istituti Fisioterapici Ospitalieri di Roma

Roma, Italy

RECRUITING

Ospedale Pediatrico Bambin Gesu'

Roma, Italy

NOT YET RECRUITING

Related Publications (34)

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MeSH Terms

Conditions

Osteosarcoma

Interventions

Surgical Procedures, Operative; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Franca Fagioli, MD/Prof

CONTACT

0039-0113135; franca.fagioli@unito.it

Sebastian D Asaftei, MD

CONTACT

0039-011 3135; sebastiandorin.asaftei@unito.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 18, 2021
• Study Start: July 30, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (16)