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CompletedNCT06662734Updated Oct 29, 2024

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

An observational study in Fibrosarcoma, sponsored by asmaa salama ibrahim. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2024-10-29.

Sponsored by asmaa salama ibrahim · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
12,783
Sex
All
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Study 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.

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Conditions studied

  • Fibrosarcoma

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Keywords

  • infantile fibrosarcoma
  • Fibrosarcoma
  • SEER
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In context

Fibrosarcoma

69 studies on the registry are indexed under Fibrosarcoma; 7 are open to participants now.

Browse Fibrosarcoma studies →

Lead sponsor

asmaa salama ibrahim is the lead sponsor of 5 studies on the registry; none are open to participants now.

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

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients with unknown histology type
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
12,783 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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

    Time frame: from Jan, 2000 till Dec, 2021

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

    Time frame: from Jan, 2000 till Dec, 2021

Secondary outcomes

  1. The standardized incidence ratio and excess risk of multiple primary malignancies in fibrosarcoma patients across different racial groups

    Time frame: from Jan, 2000 till Dec, 2021

  2. The standardized incidence ratio and excess risk of multiple primary malignancies in both males and females in fibrosarcoma patients

    Time frame: from Jan, 2000 till Dec, 2021

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Study locations

1 site
  • Suez Canal University
    Ismailia, 41512, Egypt
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2000 to primary completion in Dec 2021, 263 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 23, 2024
First posted
Oct 29, 2024
StartActual
Jan 1, 2000
Primary completionActual
Dec 30, 2021
CompletionActual
Dec 30, 2021
Last update
Oct 29, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 29, 2024, 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
NCT06662734
Lead sponsor
asmaa salama ibrahim
Responsible party
asmaa salama ibrahim (Resident physician of gastroenterology, Suez Canal University) — Sponsor-investigator
First posted
Oct 29, 2024
Start date
Jan 1, 2000
Primary completion
Dec 30, 2021
Completion
Dec 30, 2021
Last update
Oct 29, 2024

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 Oct 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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