Periosteal ChondrosarcomaPCNCT05511883
Periosteal Chondrosarcoma: a Single Institution Experience
An observational study of Periosteal Chondrosarcoma, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
Periosteal chondrosarcoma is a low-grade, malignant cartilaginous bone neoplasm that arises on the surface of bone, predominantly in the metaphysis of long bones. Periosteal chondrosarcoma is an infrequent chondrosarcoma subtype which accounts for less than 1% of all chondrosarcomas (1) and has a peak incidence in the… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Periosteal Chondrosarcoma
- How many people
- 55 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2020to 30 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 considered eligible will be included in the study, after providing a written informed consent. Since we will include cases of several decades ago, and due to the high incidence of mortality of the disease under investigation, it would be possible that some eligible subjects will be deceased.
Who may be able to join
- Male and female patients treated at Rizzoli Institute from 01 Jan 1900 to 31 Dec 2019
- Diagnosis of peristeal chondrosarcoma
- Written informed consent prior to any study-specific analysis and/or data collection
Who cannot join
- Patients with histological diagnosis different from periosteal chondrosarcoma.
Trial locations and contacts
1 site in 1 country.
About this study
Periosteal chondrosarcoma is a low-grade, malignant cartilaginous bone neoplasm that arises on the surface of bone, predominantly in the metaphysis of long bones.
Periosteal chondrosarcoma is an infrequent chondrosarcoma subtype which accounts for less than 1% of all chondrosarcomas (1) and has a peak incidence in the fourth decade (2).
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It has a reported incidence of local recurrences of 13-28% and a low metastatic potential, with distant recurrences occurring mostly in lungs (3).
Contrary to conventional chondrosarcomas, grading of periosteal chondrosarcomas seems not to predict prognosis. IDH1 and IDH2 mutations, characteristics of central chondromas/chondrosarcomas, have been also found in a subset of periosteal chondrosarcomas (1, 4).
These observations are based on the results from smaller series of cases (1, 5, 6), although the impact of histopathological characteristics on survival, local recurrence and metastases should be assessed in larger series of cases.
The aim of the present study is to review all the cases with a diagnosis of primary periosteal chondrosarcoma treated at the Rizzoli Institute from 1900 up to 31 December 2019, retrospectively.
The study will exam all the clinical, radiological, and histological features of this tumor with regard importance of medullary involvement, the IDH1/2 gene status, the types of treatment, the status of surgical margins, the presence of progression (dedifferentiation) areas and the relationship of these factors to individual outcome.
- Conditions
- Periosteal Chondrosarcoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Periosteal Chondrosarcoma: a single institution experience
the IDH1/2 gene status.
Measured: act baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start1 Apr 2020
- Primary completion15 Dec 2020
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periosteal ChondrosarcomaStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Righi, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511883
- Sponsor's protocol ID
- 136/2020
- Acronym
- PC
- Status last verified
- Sep 2021
- First submitted
- 21 Sep 2021
- Last updated
- 23 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periosteal Chondrosarcoma: a Single Institution Experience
- ClinicalTrials.gov ID
- NCT05511883
- Acronym / sponsor ID
- PC / 136/2020
- Conditions
- Periosteal Chondrosarcoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 23 Aug 2022 (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.
Periosteal chondrosarcoma is a low-grade, malignant cartilaginous bone neoplasm that arises on the surface of bone, predominantly in the metaphysis of long bones.
Periosteal chondrosarcoma is an infrequent chondrosarcoma subtype which accounts for less than 1% of all chondrosarcomas (1) and has a peak incidence in the fourth decade (2).
It has a reported incidence of local recurrences of 13-28% and a low metastatic potential, with distant recurrences occurring mostly in lungs (3).
Contrary to conventional chondrosarcomas, grading of periosteal chondrosarcomas seems not to predict prognosis. IDH1 and IDH2 mutations, characteristics of central chondromas/chondrosarcomas, have been also found in a subset of periosteal chondrosarcomas (1, 4).
These observations are based on the results from smaller series of cases (1, 5, 6), although the impact of histopathological characteristics on survival, local recurrence and metastases should be assessed in larger series of cases.
The aim of the present study is to review all the cases with a diagnosis of primary periosteal chondrosarcoma treated at the Rizzoli Institute from 1900 up to 31 December 2019, retrospectively.
The study will exam all the clinical, radiological, and histological features of this tumor with regard importance of medullary involvement, the IDH1/2 gene status, the types of treatment, the status of surgical margins, the presence of progression (dedifferentiation) areas and the relationship of these factors to individual outcome.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients considered eligible will be included in the study, after providing a written informed consent. Since we will include cases of several decades ago, and due to the high incidence of mortality of the disease under investigation, it would be possible that some eligible subjects will be deceased.
Key inclusion criteria (3 listed)
- Male and female patients treated at Rizzoli Institute from 01 Jan 1900 to 31 Dec 2019
- Diagnosis of peristeal chondrosarcoma
- Written informed consent prior to any study-specific analysis and/or data collection
Key exclusion criteria (1 listed)
- Patients with histological diagnosis different from periosteal chondrosarcoma.
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
Periosteal Chondrosarcoma: a single institution experience
Time frame: act baseline
the IDH1/2 gene status.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periosteal Chondrosarcoma, run by Istituto Ortopedico Rizzoli at 1 site 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Periosteal Chondrosarcoma: a single institution experience (time frame: act baseline). 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 23 Aug 2022.