Sarcoma,Soft TissueMFSNCT04991883
Analysis of the Molecular Profile of the Mixofibrosarcoma of the Extremities
An observational study of Sarcoma,Soft Tissue, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
Single institution case series review with a histological diagnosis of mixofibrosarcoma of the extremities from 01 Jan 1993 to 01 Dec 2017. The study will exam all the clinical, radiological, histological and immunohistochemical features of this tumour in all samples and in a limited serie of cases the presence of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoma,Soft Tissue
- What is being tested?
- case series review of clinical and histological data
- How many people
- 167 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2021to 31 Dec 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a diagnosis of Mixofibrosarcoma treated at the Rizzoli Institute from 1 January 1993 up to 01 December 2017
Who may be able to join
- Male and female patients treated at Rizzoli Institute from 01 Jan 1993 to 01 Dec 2017
- Diagnosis of mixofibrosarcoma of extremities
- Histological slides/formalin-fixed paraffin-embedded tissue tumor (FFPE) blocks from archive available to perform the histology analysis and molecular analysis
- Enough tumor biobanked material available for molecular analysis
- Presence of the biobank signed informed consent
- Written informed consent prior to any study-specific analysis and/or data collection
Who cannot join
- 1) Patients with histological diagnosis different from mixofibrosarcoma of extremities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Molecular Profile of the Mixofibrosarcoma of the Extremities: Diagnostic and Prognostic Impact
Single institution case series review with a histological diagnosis of mixofibrosarcoma of the extremities from 01 Jan 1993 to 01 Dec 2017.
The study will exam all the clinical, radiological, histological and immunohistochemical features of this tumour in all samples and in a limited serie of cases the presence of mutation of 50 genes cancer related.
- Conditions
- Sarcoma,Soft Tissue
- Being tested
- case series review of clinical and histological data
- Keywords
- Mixofibrosarcoma
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
case series review of clinical and histological dataOther
We will review all the medical records, radiological imaging, and histological data of these cases. The immunohistochemical analysis of the principal alterated genes identified in this tumor will be performed.
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival
identify patients with different risk classes in terms of disease-free survival (local and systemic recurrence).
Measured: at baseline (Day0)
overall survival
identify patients with different risk classes in terms of overall survival.
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 posted5 Aug 2021
- Study start1 Sep 2021
- Primary completion1 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sarcoma,Soft TissueStudies 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
- 167 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
- NCT04991883
- Sponsor's protocol ID
- MFS
- Acronym
- MFS
- Status last verified
- May 2023
- First submitted
- 20 Jul 2021
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mentzel T, Calonje E, Wadden C, Camplejohn RS, Beham A, Smith MA, Fletcher CD. Myxofibrosarcoma. Clinicopathologic analysis of 75 cases with emphasis on the low-grade variant. Am J Surg Pathol. 1996 Apr;20(4):391-405. doi: 10.1097/00000478-199604000-00001.
PubMed 8604805Gronchi A, Lo Vullo S, Colombo C, Collini P, Stacchiotti S, Mariani L, Fiore M, Casali PG. Extremity soft tissue sarcoma in a series of patients treated at a single institution: local control directly impacts survival. Ann Surg. 2010 Mar;251(3):506-11. doi: 10.1097/SLA.0b013e3181cf87fa.
PubMed 20130465Kaya M, Wada T, Nagoya S, Sasaki M, Matsumura T, Yamaguchi T, Hasegawa T, Yamashita T. MRI and histological evaluation of the infiltrative growth pattern of myxofibrosarcoma. Skeletal Radiol. 2008 Dec;37(12):1085-90. doi: 10.1007/s00256-008-0542-4. Epub 2008 Jul 16.
PubMed 18629459
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Molecular Profile of the Mixofibrosarcoma of the Extremities: Diagnostic and Prognostic Impact
- ClinicalTrials.gov ID
- NCT04991883
- Acronym / sponsor ID
- MFS / MFS
- Conditions
- Sarcoma,Soft Tissue
- Keywords
- Mixofibrosarcoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 5 Aug 2021 (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 case series review with a histological diagnosis of mixofibrosarcoma of the extremities from 01 Jan 1993 to 01 Dec 2017.
The study will exam all the clinical, radiological, histological and immunohistochemical features of this tumour in all samples and in a limited serie of cases the presence of mutation of 50 genes cancer related.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of Mixofibrosarcoma treated at the Rizzoli Institute from 1 January 1993 up to 01 December 2017
Key inclusion criteria (6 listed)
- Male and female patients treated at Rizzoli Institute from 01 Jan 1993 to 01 Dec 2017
- Diagnosis of mixofibrosarcoma of extremities
- Histological slides/formalin-fixed paraffin-embedded tissue tumor (FFPE) blocks from archive available to perform the histology analysis and molecular analysis
- Enough tumor biobanked material available for molecular analysis
- Presence of the biobank signed informed consent
Key exclusion criteria (1 listed)
- 1) Patients with histological diagnosis different from mixofibrosarcoma of extremities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| case series review of clinical and histological dataWe will review all the medical records, radiological imaging, and histological data of these cases. The immunohistochemical analysis of the principal alterated genes identified in this tumor will be performed. | Other | – |
Primary outcome
disease-free survival
Time frame: at baseline (Day0)
identify patients with different risk classes in terms of disease-free survival (local and systemic recurrence).
overall survival
Time frame: at baseline (Day0)
identify patients with different risk classes in terms of overall survival.
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 19 May 2023.
- Results publication: PubMed 8604805Mentzel T, Calonje E, Wadden C, Camplejohn RS, Beham A, Smith MA, Fletcher CD. Myxofibrosarcoma. Clinicopathologic analysis of 75 cases with emphasis on the low-grade variant. Am J Surg Pathol. 1996 Apr;20(4):391-405. doi: 10.1097/00000478-199604000-00001.
- Results publication: PubMed 20130465Gronchi A, Lo Vullo S, Colombo C, Collini P, Stacchiotti S, Mariani L, Fiore M, Casali PG. Extremity soft tissue sarcoma in a series of patients treated at a single institution: local control directly impacts survival. Ann Surg. 2010 Mar;251(3):506-11. doi: 10.1097/SLA.0b013e3181cf87fa.
- Results publication: PubMed 18629459Kaya M, Wada T, Nagoya S, Sasaki M, Matsumura T, Yamaguchi T, Hasegawa T, Yamashita T. MRI and histological evaluation of the infiltrative growth pattern of myxofibrosarcoma. Skeletal Radiol. 2008 Dec;37(12):1085-90. doi: 10.1007/s00256-008-0542-4. Epub 2008 Jul 16.
- Individual participant dataSharing planned: No
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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 Sarcoma,Soft Tissue, 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 6 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 19 May 2023. 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?
disease-free survival (time frame: at baseline (Day0)). The study lists 2 primary outcomes in all. 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 NCT04991883, which also lists 3 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 19 May 2023.