Acute Myeloid Leukemia (AML)NCT06659224
The Risk of Acute Myeloid Leukaemia in Patients With Ewing's Sarcoma
An observational study of Acute Myeloid Leukemia (AML) and Ewing Sarcoma, run by asmaa salama ibrahim at 1 site in Egypt.
Trial summary
Ewing's sarcoma is an uncommon yet vital malignancy of bone. It demonstrates a predilection for the pediatric and young adult population. Chemotherapy is considered an important treatment modality for Ewing's sarcoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Myeloid Leukemia (AML), Ewing Sarcoma
- How many people
- 2,631 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: Patients diagnosed with Ewing sarcoma between 2000 and 2021, followed up for more than 10 years after the initial diagnosis. Site record ICD-O-3/WHO 2008 restricted to bone and soft tissue; and histological type ICD-O-3 specified as Ewing sarcoma (9364)
Who may be able to join
- Patients diagnosed with Ewing sarcoma
- Latency exclusion period of 6 months
- Sequence 0 or 1
Who cannot join
- patients lacking age documentation or age reported only on death certificates or autopsies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Risk of Developing Acute Myeloid Leukaemia in Patients With Ewing's Sarcoma: A SEER-based Study
Ewing's sarcoma is an uncommon yet vital malignancy of bone. It demonstrates a predilection for the pediatric and young adult population. Chemotherapy is considered an important treatment modality for Ewing's sarcoma. However, the development of therapy-related leukemia, especially acute myeloid leukemia following treatment, is attributed to the use of substances such as alkylating agents and topoisomerase inhibitors which are genotoxic. There is a very few studies elaborating on the incidence rates of such complications. So, our aim is to quantify the risk of developing acute myeloid leukemia in Ewing sarcoma patients and provide an updated evidence to the literature.
- Conditions
- Acute Myeloid Leukemia (AML), Ewing Sarcoma
- Keywords
- acute myeloid leukemia, Ewing sarcoma, SEER
- Medical subject headings
- Leukemia, Myeloid, Acute, Sarcoma, Ewing
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 acute myeloid leukemia in Ewing's sarcoma patients
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 acute myeloid leukemia in Ewing's sarcoma patients.
Measured: from Jan, 2000 till Dec, 2021
Secondary outcomes (2)
The standardized incidence ratio and excess risk of second primary malignancies in Ewing's sarcoma patients across different racial groups
Measured: from Jan, 2000 till Dec, 2021
The standardized incidence ratio and excess risk of second primary malignancies in Ewing's sarcoma patients between different stages
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 posted26 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 Acute Myeloid Leukemia (AML)Studies 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
- 2,631 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
- Investigators
- Asmaa Ellaithy, MD, Principal investigator, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06659224
- Sponsor's protocol ID
- A275
- Status last verified
- Jul 2025
- First submitted
- 23 Oct 2024
- Last updated
- 23 Jul 2025
- 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 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Risk of Developing Acute Myeloid Leukaemia in Patients With Ewing's Sarcoma: A SEER-based Study
- ClinicalTrials.gov ID
- NCT06659224
- Acronym / sponsor ID
- A275
- Conditions
- Acute Myeloid Leukemia (AML), Ewing Sarcoma
- Keywords
- acute myeloid leukemia, Ewing sarcoma, SEER
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,631 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
- 26 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.
Ewing's sarcoma is an uncommon yet vital malignancy of bone. It demonstrates a predilection for the pediatric and young adult population. Chemotherapy is considered an important treatment modality for Ewing's sarcoma. However, the development of therapy-related leukemia, especially acute myeloid leukemia following treatment, is attributed to the use of substances such as alkylating agents and topoisomerase inhibitors which are genotoxic. There is a very few studies elaborating on the incidence rates of such complications. So, our aim is to quantify the risk of developing acute myeloid leukemia in Ewing sarcoma patients and provide an updated evidence to the literature.
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
- Patients diagnosed with Ewing sarcoma between 2000 and 2021, followed up for more than 10 years after the initial diagnosis. Site record ICD-O-3/WHO 2008 restricted to bone and soft tissue; and histological type ICD-O-3 specified as Ewing sarcoma (9364)
Key inclusion criteria (3 listed)
- Patients diagnosed with Ewing sarcoma
- Latency exclusion period of 6 months
- Sequence 0 or 1
Key exclusion criteria (1 listed)
- patients lacking age documentation or age reported only on death certificates or autopsies
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 acute myeloid leukemia in Ewing's sarcoma patients
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 acute myeloid leukemia in Ewing's sarcoma patients.
2 secondary outcomes
The standardized incidence ratio and excess risk of second primary malignancies in Ewing's sarcoma patients across different racial groups
Time frame: from Jan, 2000 till Dec, 2021
The standardized incidence ratio and excess risk of second primary malignancies in Ewing's sarcoma patients between different stages
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 23 Jul 2025.
- 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.
Asmaa Ellaithy, MD principal investigator
Suez Canal University
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 Acute Myeloid Leukemia (AML) and Ewing Sarcoma, 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 3 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 23 Jul 2025. 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 acute myeloid leukemia in Ewing's sarcoma patients (time frame: from Jan, 2000 till Dec, 2021). 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 23 Jul 2025.