NCT06659224

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,631

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
22 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 26, 2024

Completed
Last Updated

July 23, 2025

Status Verified

July 1, 2025

Enrollment Period

22 years

First QC Date

October 23, 2024

Last Update Submit

July 18, 2025

Conditions

Keywords

acute myeloid leukemiaEwing sarcomaSEER

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    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

    from Jan, 2000 till Dec, 2021

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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)

You may qualify if:

  • Patients diagnosed with Ewing sarcoma
  • Sequence 0 or 1

You may not qualify if:

  • patients lacking age documentation or age reported only on death certificates or autopsies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suez Canal University

Ismailia, 41512, Egypt

Location

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteSarcoma, Ewing

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesOsteosarcomaNeoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueSarcoma

Study Officials

  • Asmaa Ellaithy, MD

    Suez Canal University

    PRINCIPAL INVESTIGATOR

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 26, 2024

Study Start

January 1, 2000

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

July 23, 2025

Record last verified: 2025-07

Locations