Analysis of the Molecular Profile of the Mixofibrosarcoma of the Extremities

Sarcoma,Soft Tissue Clinical Trial

— MFS  

Official title:

Analysis of the Molecular Profile of the Mixofibrosarcoma of the Extremities: Diagnostic and Prognostic Impact

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04991883
• Other study ID #: MFS
• Status: Completed
• Start date: September 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2023
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 mutation of 50 genes cancer related.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 167
• Est. completion date: December 31, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

1) Patients with histological diagnosis different from mixofibrosarcoma of extremities

Related Conditions & MeSH terms

• Sarcoma
• Sarcoma,Soft Tissue

Intervention

Other:
• case 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.

Locations

Country	Name	City	State
Italy	Istituto Ortopedico Rizzoli	Bologna	BO

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. do — View Citation

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 2 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease-free survival	identify patients with different risk classes in terms of disease-free survival (local and systemic recurrence).	at baseline (Day0)
Primary	overall survival	identify patients with different risk classes in terms of overall survival.	at baseline (Day0)