FibrosarcomaNCT06662734
Infantile Versus Adult-type Fibrosarcoma and the Risk of Multiple Primary Malignancies
An observational study of Fibrosarcoma, run by asmaa salama ibrahim at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fibrosarcoma
- How many people
- 12,783 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2000to 30 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study included 12,783 patients diagnosed with fibrosarcoma between 2000 and 2021.
Who may be able to join
- 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
Who cannot join
- Patients with unknown histology type
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Infantile Versus Adult-type Fibrosarcoma and the Risk of Multiple Primary Malignancies: a Retrospective Cohort Based on SEER Database
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
- Medical subject headings
- Fibrosarcoma
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from Jan, 2000 till Dec, 2021
The standardized incidence ratio and excess risk of developing second primary malignancies for different subtypes of fibrosarcoma
Measured: 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
Measured: 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
Measured: from Jan, 2000 till Dec, 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start1 Jan 2000
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibrosarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 12,783 participants (actual)
Sponsor and investigators
- Lead sponsor
- asmaa salama ibrahim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, asmaa salama ibrahim, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662734
- Sponsor's protocol ID
- A274
- Status last verified
- Oct 2024
- First submitted
- 23 Oct 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Infantile Versus Adult-type Fibrosarcoma and the Risk of Multiple Primary Malignancies: a Retrospective Cohort Based on SEER Database
- ClinicalTrials.gov ID
- NCT06662734
- Acronym / sponsor ID
- A274
- Conditions
- Fibrosarcoma
- Keywords
- infantile fibrosarcoma, Fibrosarcoma, SEER
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12,783 participants (actual)
- Lead sponsor
- asmaa salama ibrahimUniversity, hospital or other
- Study start
- 1 Jan 2000 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study included 12,783 patients diagnosed with fibrosarcoma between 2000 and 2021.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with unknown histology type
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The standardized incidence ratio and excess risk of developing multiple primary malignancies following fibrosarcoma diagnosis
Time frame: 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
Time frame: from Jan, 2000 till Dec, 2021
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibrosarcoma, run by asmaa salama ibrahim at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The standardized incidence ratio and excess risk of developing multiple primary malignancies following fibrosarcoma diagnosis (time frame: from Jan, 2000 till Dec, 2021). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.