Infantile Versus Adult-type Fibrosarcoma and the Risk of Multiple Primary Malignancies

Completed

• Conditions: Fibrosarcoma

• Registration Number: NCT06662734
• Lead Sponsor: asmaa salama ibrahim

Brief Summary

Fibrosarcoma is a malignant tumor originating from mesenchymal tissues and consists of fibroblasts with various types of collagen production. It represents 10% of musculoskeletal sarcomas and less than 5% of all primary bone tumors. It affects middle-aged patients with the most common location in the femur and 70% long tubular bones. Studies reported that fibrosarcoma patients tend to develop a subsequent primary malignancy, the analysis showed a higher risk of SPMs even a decade following the initial diagnosis of fibrosarcoma.

SPMs affect the long-term survival of patients with soft tissue tumors, and since there are no available studies analyzing the risk of second primary malignancies in different types of fibrosarcomas, especially the infantile and adult-type. Therefore, the purpose of this study was to assess the risk of second primary malignancies following primary fibrosarcoma diagnosis for a better understanding of the nature of this rare neoplasm. The investigators used the Surveillance, Epidemiology and End Results (SEER) database to extract the data and calculate the standardized incidence ratio as Observed/Expected and the Excess risk for second primary malignancies with 95% Confidence Interval. Significance was achieved at 0.05.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-01-01
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30
• Status Verified: 2024-10
• Study First Submitted: 2024-10-23
• Study First Submitted QC: 2024-10-25
• Last Update Submitted: 2024-10-25
• Study First Posted: 2024-10-29
• Last Update Posted: 2024-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12783

Inclusion Criteria

• Patients diagnosed with fibrosarcoma from 2000 to 2021.
• Sequence 0 or 1.
• Histological types:

Infantile fibrosarcoma, Fibromyxosarcoma, Periosteal fibrosarcoma, Facial fibrosarcoma, Dermatofibrosarcoma, Central odontogenic fibrosarcoma, Ameloblastic fibrosarcoma

Exclusion Criteria

• Patients with unknown histology type

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The standardized incidence ratio and excess risk of developing multiple primary malignancies following fibrosarcoma diagnosis	from Jan, 2000 till Dec, 2021	The surveillance, epidemiology and End Results (SEER) database was used to calculate the standardized incidence ratio (SIR) as Observed/Expected (O/E) and calculated the Excess absolute risk for Multiple primary malignancies for fibrosarcoma patients
The standardized incidence ratio and excess risk of developing second primary malignancies for different subtypes of fibrosarcoma	from Jan, 2000 till Dec, 2021

Secondary Outcome Measures

Name	Time	Method
The standardized incidence ratio and excess risk of multiple primary malignancies in fibrosarcoma patients across different racial groups	from Jan, 2000 till Dec, 2021
The standardized incidence ratio and excess risk of multiple primary malignancies in both males and females in fibrosarcoma patients	from Jan, 2000 till Dec, 2021

Trial Locations

Locations (1)

Suez Canal University; 🇪🇬 Ismailia, Egypt