OsteosarcomaOSTEO LRNCT06017518
An Observational Study of Local Relapse After High Grade Osteosarcoma
An observational study of Osteosarcoma, run by Istituto Ortopedico Rizzoli at 2 sites in Italy.
Trial summary
multicenter retrospective and prospective study in patients with high-grade osteosarcoma Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteosarcoma
- How many people
- 150 participants
- Where
- 2 sitesItaly
- Study dates
- 13 Jun 2022to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who experienced local relapse as first event of recurrence after treatment for localized high-grade osteosarcoma of bone, including cases with synchronous lung metastases
Who may be able to join
- Patients who experienced LR as first event of recurrence after treatment for localized high-grade osteosarcoma of bone, including cases with synchronous lung metastases
- Adequate patient compliance to follow-up visits
- Written informed consent prior to any study-specific analysis and/or data collection
- No age limits
Who cannot join
- Cases of LR demonstrated after > 3 months after metastatic disease
- Impossibility to ensure adequate compliance
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
IRCCS Istituto Ortopedico Rizzoli
Bologna, BO, 40136
Emanuela Palmerini, MD, 051/6366 ext. 668, emanuela.palmerini@ior.it
- Recruiting
Azienda Ospedaliero-Universitaria Pisana
Pisa, PI, 56126
Luca Coccoli, MD, l.coccoli@ao-pisa.toscana.it
About this study
multicenter retrospective and prospective study in patients with high-grade osteosarcoma
Read the detailed description
This is a multicenter retrospective and prospective study that will analyze all cases with of diagnosis of local relapse in high-grade osteosarcoma from 01 January 1980 and all new cases referring to each participant site.
- Conditions
- Osteosarcoma
- Medical subject headings
- Osteosarcoma
What is being measured
The primary outcome is the main question the study is designed to answer.
post local relapse survival
the aim of the study is to analyse the factors influencing post local relapse survival
Measured: 24 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start13 Jun 2022
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteosarcomaStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06017518
- Sponsor's protocol ID
- OSTEO LR
- Acronym
- OSTEO LR
- Status last verified
- Sep 2025
- First submitted
- 24 Aug 2023
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of Local Relapse After High Grade Osteosarcoma
- ClinicalTrials.gov ID
- NCT06017518
- Acronym / sponsor ID
- OSTEO LR / OSTEO LR
- Conditions
- Osteosarcoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
multicenter retrospective and prospective study in patients with high-grade osteosarcoma
Detailed description
This is a multicenter retrospective and prospective study that will analyze all cases with of diagnosis of local relapse in high-grade osteosarcoma from 01 January 1980 and all new cases referring to each participant site.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who experienced local relapse as first event of recurrence after treatment for localized high-grade osteosarcoma of bone, including cases with synchronous lung metastases
Key inclusion criteria (4 listed)
- Patients who experienced LR as first event of recurrence after treatment for localized high-grade osteosarcoma of bone, including cases with synchronous lung metastases
- Adequate patient compliance to follow-up visits
- Written informed consent prior to any study-specific analysis and/or data collection
- No age limits
Key exclusion criteria (2 listed)
- Cases of LR demonstrated after > 3 months after metastatic disease
- Impossibility to ensure adequate compliance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
post local relapse survival
Time frame: 24 months follow up
the aim of the study is to analyse the factors influencing post local relapse survival
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteosarcoma, run by Istituto Ortopedico Rizzoli at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emanuela Palmerini, MD (051/6366 ext. 668, emanuela.palmerini@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post local relapse survival (time frame: 24 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.