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CompletedNCT04991883MFSUpdated May 19, 2023

Analysis of the Molecular Profile of the Mixofibrosarcoma of the Extremities

An observational study in Sarcoma,Soft Tissue, sponsored by Istituto Ortopedico Rizzoli. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-19.

Sponsored by Istituto Ortopedico Rizzoli · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
167
Ages
18 Years and older
Sex
All
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Study 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 mutation of 50 genes cancer related.

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Conditions studied

  • Sarcoma,Soft Tissue

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Keywords

  • Mixofibrosarcoma
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In context

Sarcoma

1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.

This study's enrollment of 167 is above the median of 121 across 238 observational studies indexed under Sarcoma.

Browse Sarcoma studies →

Lead sponsor

Istituto Ortopedico Rizzoli is the lead sponsor of 298 studies on the registry; 102 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with a diagnosis of Mixofibrosarcoma treated at the Rizzoli Institute from 1 January 1993 up to 01 December 2017

Inclusion criteria

  1. Male and female patients treated at Rizzoli Institute from 01 Jan 1993 to 01 Dec 2017
  2. Diagnosis of mixofibrosarcoma of extremities
  3. Histological slides/formalin-fixed paraffin-embedded tissue tumor (FFPE) blocks from archive available to perform the histology analysis and molecular analysis
  4. Enough tumor biobanked material available for molecular analysis
  5. Presence of the biobank signed informed consent
  6. Written informed consent prior to any study-specific analysis and/or data collection

Exclusion criteria

Exclusion Criteria:

  1. Patients with histological diagnosis different from mixofibrosarcoma of extremities
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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
167 participants (actual)
Patient registry
No

Interventions

  • Othercase series review of clinical and histological data

    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.

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What researchers measure

Primary outcomes

  1. disease-free survival

    identify patients with different risk classes in terms of disease-free survival (local and systemic recurrence).

    Time frame: at baseline (Day0)

  2. overall survival

    identify patients with different risk classes in terms of overall survival.

    Time frame: at baseline (Day0)

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Study locations

1 site
  • Istituto Ortopedico Rizzoli
    Bologna, BO 40136, Italy
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References and documents

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 8604805 ↗
  • Gronchi 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 20130465 ↗
  • Kaya 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 documents

  • Study protocol · Jun 12, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 19, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04991883
Lead sponsor
Istituto Ortopedico Rizzoli
Responsible party
Sponsor
First posted
Aug 5, 2021
Start date
Sep 1, 2021
Primary completion
Dec 1, 2022
Completion
Dec 31, 2022
Last update
May 19, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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