Parosteal OsteosarcomaNCT03768076
an Istitution Experience on Parosteal OsTeosarcoma
An observational study of Parosteal Osteosarcoma, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
single institution cases series review of histological and clinical data Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parosteal Osteosarcoma
- How many people
- 220 participants
- Where
- 1 siteItaly
- Study dates
- 30 Nov 2018to 28 Feb 2019
- 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
- Child, Adult, Older adult
Study population: male and female with diagnosis of parosteal osteosarcoma treated at Rizzoli institute from 01 Jan 1900 to 31 Jul 2018
Who may be able to join
- Male and female patients treated at Rizzoli Institute from 01 Jan 1900 to 31 Jul 2018
- Diagnosis of parosteal osteosarcoma
- Written informed consent prior to any study-specific analysis and/or data collection
Who cannot join
- Patients with histological diagnosis different from parosteal osteosarcoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Parosteal OsTeosarcoma: a Single Istitution Experience
single institution cases series review of histological and clinical data
Read the detailed description
Investigators will review all the cases with a diagnosis of primary parosteal osteosarcoma treated at the Rizzoli Institute from 1900 up to 31 July 2018, retrospectively.
- Conditions
- Parosteal Osteosarcoma
- Medical subject headings
- Osteosarcoma, Juxtacortical
What is being measured
The primary outcome is the main question the study is designed to answer.
retrospective analysis of cases of Parosteal osteosarcoma
Investigators will exam the presence of progression (dedifferentiation) areas and the relationship of these factors to individual outcome.
Measured: at baseline (Day0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start30 Nov 2018
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Parosteal OsteosarcomaStudies of the same condition, open and under way.
- 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
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768076
- Sponsor's protocol ID
- POsT
- Status last verified
- Jul 2021
- First submitted
- 22 Nov 2018
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No Individual Patient Data sharing plan has been implemented
Publications
Han I, Oh JH, Na YG, Moon KC, Kim HS. Clinical outcome of parosteal osteosarcoma. J Surg Oncol. 2008 Feb 1;97(2):146-9. doi: 10.1002/jso.20902.
PubMed 18050289Bertoni F, Bacchini P, Staals EL, Davidovitz P. Dedifferentiated parosteal osteosarcoma: the experience of the Rizzoli Institute. Cancer. 2005 Jun 1;103(11):2373-82. doi: 10.1002/cncr.21039.
PubMed 15852358Okada K, Frassica FJ, Sim FH, Beabout JW, Bond JR, Unni KK. Parosteal osteosarcoma. A clinicopathological study. J Bone Joint Surg Am. 1994 Mar;76(3):366-78. doi: 10.2106/00004623-199403000-00007.
PubMed 8126042Laitinen M, Parry M, Albergo JI, Jeys L, Abudu A, Carter S, Sumathi V, Grimer R. The prognostic and therapeutic factors which influence the oncological outcome of parosteal osteosarcoma. Bone Joint J. 2015 Dec;97-B(12):1698-703. doi: 10.1302/0301-620X.97B12.35749.
PubMed 26637687
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parosteal OsTeosarcoma: a Single Istitution Experience
- ClinicalTrials.gov ID
- NCT03768076
- Acronym / sponsor ID
- POsT
- Conditions
- Parosteal Osteosarcoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 7 Dec 2018 (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.
single institution cases series review of histological and clinical data
Detailed description
Investigators will review all the cases with a diagnosis of primary parosteal osteosarcoma treated at the Rizzoli Institute from 1900 up to 31 July 2018, retrospectively.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- male and female with diagnosis of parosteal osteosarcoma treated at Rizzoli institute from 01 Jan 1900 to 31 Jul 2018
Key inclusion criteria (3 listed)
- Male and female patients treated at Rizzoli Institute from 01 Jan 1900 to 31 Jul 2018
- Diagnosis of parosteal osteosarcoma
- Written informed consent prior to any study-specific analysis and/or data collection
Key exclusion criteria (1 listed)
- Patients with histological diagnosis different from parosteal osteosarcoma
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
retrospective analysis of cases of Parosteal osteosarcoma
Time frame: at baseline (Day0)
Investigators will exam the presence of progression (dedifferentiation) areas and the relationship of these factors to individual outcome.
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 5 Aug 2021.
- Results publication: PubMed 18050289Han I, Oh JH, Na YG, Moon KC, Kim HS. Clinical outcome of parosteal osteosarcoma. J Surg Oncol. 2008 Feb 1;97(2):146-9. doi: 10.1002/jso.20902.
- Results publication: PubMed 15852358Bertoni F, Bacchini P, Staals EL, Davidovitz P. Dedifferentiated parosteal osteosarcoma: the experience of the Rizzoli Institute. Cancer. 2005 Jun 1;103(11):2373-82. doi: 10.1002/cncr.21039.
- Results publication: PubMed 8126042Okada K, Frassica FJ, Sim FH, Beabout JW, Bond JR, Unni KK. Parosteal osteosarcoma. A clinicopathological study. J Bone Joint Surg Am. 1994 Mar;76(3):366-78. doi: 10.2106/00004623-199403000-00007.
- Results publication: PubMed 26637687Laitinen M, Parry M, Albergo JI, Jeys L, Abudu A, Carter S, Sumathi V, Grimer R. The prognostic and therapeutic factors which influence the oncological outcome of parosteal osteosarcoma. Bone Joint J. 2015 Dec;97-B(12):1698-703. doi: 10.1302/0301-620X.97B12.35749.
- Individual participant dataSharing planned: No. No Individual Patient Data sharing plan has been implemented
Related trials for Parosteal Osteosarcoma
Not yet recruitingObservational study
Registry For Children, Adolescents And Adults With Osteosarcoma And Biologically Related Bone Sarcomas
Osteosarcoma, Bone Tumor
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 Parosteal Osteosarcoma, 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 5 Aug 2021. 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?
retrospective analysis of cases of Parosteal osteosarcoma (time frame: at baseline (Day0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03768076, which also lists 4 linked publications.
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 5 Aug 2021.