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

NCT06662734 | Completed

• 1 other identifier: A274
• Study Type: observational
• Target: 12,783
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibrosarcoma

Keywords

infantile fibrosarcoma; Fibrosarcoma; SEER

Outcome Measures

Primary Outcomes (2)

• The standardized incidence ratio and excess risk of developing multiple primary malignancies following fibrosarcoma diagnosis

  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

  from Jan, 2000 till Dec, 2021

• The standardized incidence ratio and excess risk of developing second primary malignancies for different subtypes of fibrosarcoma

  from Jan, 2000 till Dec, 2021

Secondary Outcomes (2)

• 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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study included 12,783 patients diagnosed with fibrosarcoma between 2000 and 2021.

You may qualify if:

• 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

You may not qualify if:

• Patients with unknown histology type

Sponsors & Collaborators

• asmaa salama ibrahim: lead

Study Sites (1)

Suez Canal University

Ismailia, 41512, Egypt

Location

MeSH Terms

Conditions

Fibrosarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident physician of gastroenterology

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 29, 2024
• Study Start: January 1, 2000
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: October 29, 2024

Record last verified: 2024-10

Locations

EG (1)