NCT04991883

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
167

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2021

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 5, 2021

Completed
27 days until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 19, 2023

Status Verified

May 1, 2023

Enrollment Period

1.2 years

First QC Date

July 20, 2021

Last Update Submit

May 18, 2023

Conditions

Keywords

Mixofibrosarcoma

Outcome Measures

Primary Outcomes (2)

  • disease-free survival

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

    at baseline (Day0)

  • overall survival

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

    at baseline (Day0)

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • \) Patients with histological diagnosis different from mixofibrosarcoma of extremities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, BO, 40136, Italy

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2021

First Posted

August 5, 2021

Study Start

September 1, 2021

Primary Completion

December 1, 2022

Study Completion

December 31, 2022

Last Updated

May 19, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations