Synovial ChondrosarcomaNCT03776942
Synovial Chondrosarcoma: a Single Institution Experience
An observational study of Synovial Chondrosarcoma, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
single institution cases series review of histological, radiological and clinical data Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Synovial Chondrosarcoma
- How many people
- 9 participants
- Where
- 1 siteItaly
- Study dates
- 7 Aug 2018to 31 Aug 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Male and Female ≥ 18 years with diagnosis of synovial chondrosarcoma with histological slides/formalin-fixed paraffin-embedded tissue tumor blocks from archive available to perform the histology analysis
Who may be able to join
- Male and female patients treated at Rizzoli Institute from 01 January 1982 to 31 December 2017
- Diagnosis of synovial chondrosarcoma
- Age ≥ 18 years
- Histological slides / formalin-fixed paraffin-embedded tissue tumor (FFPE) blocks from archive available to perform the histology analysis
- Written informed consent prior to any study-specific analysis and/or data collection
Who cannot join
- Patients with histological diagnosis different from synovial chondrosarcoma
Trial locations and contacts
1 site in 1 country.
About this study
single institution cases series review of histological, radiological and clinical data
Read the detailed description
single institution cases series review of histological, radiological and clinical data. Investigators will retrieve from the archives of the Rizzoli institute all the cases with a histological diagnosis of synovial chondrosarcoma.
- Conditions
- Synovial Chondrosarcoma
What is being measured
The primary outcome is the main question the study is designed to answer.
selection and review of cases of Synovial Chondrosarcoma
IDH1 and IDH2 analysis will be performed in order to better understand tumor characteristics and to identify the best therapeutic approach.
Measured: baseline (Day0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start7 Aug 2018
- Primary completion1 Dec 2018
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Synovial ChondrosarcomaStudies 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
- 9 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
- NCT03776942
- Sponsor's protocol ID
- SynoChondroS
- Status last verified
- Dec 2018
- First submitted
- 10 Dec 2018
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ng VY, Louie P, Punt S, Conrad EU. Malignant Transformation of Synovial Chondromatosis: A Systematic Review. Open Orthop J. 2017 May 31;11:517-524. doi: 10.2174/1874325001711010517. eCollection 2017.
PubMed 28694891Biazzo A, Confalonieri N. Synovial chondrosarcoma. Ann Transl Med. 2016 Aug;4(15):280. doi: 10.21037/atm.2016.06.23.
PubMed 27570774Zamora EE, Mansor A, Vanel D, Errani C, Mercuri M, Picci P, Alberghini M. Synovial chondrosarcoma: report of two cases and literature review. Eur J Radiol. 2009 Oct;72(1):38-43. doi: 10.1016/j.ejrad.2009.05.029. Epub 2009 Jun 11.
PubMed 19523777Campanacci DA, Matera D, Franchi A, Capanna R. Synovial chondrosarcoma of the hip: report of two cases and literature review. Chir Organi Mov. 2008 Dec;92(3):139-44. doi: 10.1007/s12306-008-0062-3. Epub 2008 Dec 4.
PubMed 19057985Bertoni F, Unni KK, Beabout JW, Sim FH. Chondrosarcomas of the synovium. Cancer. 1991 Jan 1;67(1):155-62. doi: 10.1002/1097-0142(19910101)67:13.0.co;2-w.
PubMed 1985712
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synovial Chondrosarcoma: a Single Institution Experience
- ClinicalTrials.gov ID
- NCT03776942
- Acronym / sponsor ID
- SynoChondroS
- Conditions
- Synovial Chondrosarcoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 17 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, radiological and clinical data
Detailed description
single institution cases series review of histological, radiological and clinical data. Investigators will retrieve from the archives of the Rizzoli institute all the cases with a histological diagnosis of synovial chondrosarcoma.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Male and Female ≥ 18 years with diagnosis of synovial chondrosarcoma with histological slides/formalin-fixed paraffin-embedded tissue tumor blocks from archive available to perform the histology analysis
Key inclusion criteria (5 listed)
- Male and female patients treated at Rizzoli Institute from 01 January 1982 to 31 December 2017
- Diagnosis of synovial chondrosarcoma
- Age ≥ 18 years
- Histological slides / formalin-fixed paraffin-embedded tissue tumor (FFPE) blocks from archive available to perform the histology analysis
- Written informed consent prior to any study-specific analysis and/or data collection
Key exclusion criteria (1 listed)
- Patients with histological diagnosis different from synovial 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
selection and review of cases of Synovial Chondrosarcoma
Time frame: baseline (Day0)
IDH1 and IDH2 analysis will be performed in order to better understand tumor characteristics and to identify the best therapeutic approach.
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 13 Feb 2020.
- Results publication: PubMed 28694891Ng VY, Louie P, Punt S, Conrad EU. Malignant Transformation of Synovial Chondromatosis: A Systematic Review. Open Orthop J. 2017 May 31;11:517-524. doi: 10.2174/1874325001711010517. eCollection 2017.
- Results publication: PubMed 27570774Biazzo A, Confalonieri N. Synovial chondrosarcoma. Ann Transl Med. 2016 Aug;4(15):280. doi: 10.21037/atm.2016.06.23.
- Results publication: PubMed 19523777Zamora EE, Mansor A, Vanel D, Errani C, Mercuri M, Picci P, Alberghini M. Synovial chondrosarcoma: report of two cases and literature review. Eur J Radiol. 2009 Oct;72(1):38-43. doi: 10.1016/j.ejrad.2009.05.029. Epub 2009 Jun 11.
- Results publication: PubMed 19057985Campanacci DA, Matera D, Franchi A, Capanna R. Synovial chondrosarcoma of the hip: report of two cases and literature review. Chir Organi Mov. 2008 Dec;92(3):139-44. doi: 10.1007/s12306-008-0062-3. Epub 2008 Dec 4.
- Results publication: PubMed 1985712Bertoni F, Unni KK, Beabout JW, Sim FH. Chondrosarcomas of the synovium. Cancer. 1991 Jan 1;67(1):155-62. doi: 10.1002/1097-0142(19910101)67:13.0.co;2-w.
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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 Synovial 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 5 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 13 Feb 2020. 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?
selection and review of cases of Synovial Chondrosarcoma (time frame: 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 NCT03776942, which also lists 5 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 13 Feb 2020.