- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04300179
Ewing Sarcoma Family of Tumors (ESFT): A 15-year Experience From a Tertiary Care Cancer Center in Upper Egypt
December 16, 2020 updated by: Ahmed Mohammed Morsy, MD, Assiut University
The aim of this study is to identify demographic & disease characteristics in pediatric oncology patients diagnosed with Ewing Sarcoma Family of Tumors (ESFT) & treatment outcomes in these patients.
Study Overview
Status
Completed
Conditions
Detailed Description
Ewing sarcoma (ES) and peripheral primitive neuroectodermal tumor (PNET), Both entities that currently comprise the same spectrum of neoplastic diseases known as the Ewing sarcoma family of tumors (EFT), were originally described as distinct clinicopathologic entities.
Primitive neuroectodermal tumors (PNETs) first described in 1918 by Stout as a malignant tumor arising from major nerve.
Later, in 1921, ES was described as an undifferentiated tumor involving the diaphysis of long bones.
It was also reported to arise in soft tissue (extraosseous ES).
EFT is aggressive malignant small round cell tumors of bone and soft-tissue that predominantly affecting children and young adults.
Study Type
Observational
Enrollment (Actual)
59
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Assiut, Egypt
- South Egypt Cancer Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 19 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Pediatric cancer patients, those diagnosed with Ewing Sarcoma Family of Tumors (ESFT), in the period from 2000 January till 2015 December, and received treatment at the pediatric oncology department, their medical records will be retrospectively reviewed for data collection.
Description
Inclusion Criteria:
- Patients whose age less than 19 years. Patients diagnosed with Ewing Sarcoma Family of Tumors (ESFT).
Exclusion Criteria:
- Patients whose age more than 19 years. Patients diagnosed with other bone & soft tissue neoplasms.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival (OS)
Time Frame: From date of treatment initiation until the date of death from any cause or patients censored at last follow up, whichever came first, assessed up to 60 months
|
Participants will be retrospectively followed forward in time from the date of initiation of treatment till death from any cause, an expected average of 5 years
|
From date of treatment initiation until the date of death from any cause or patients censored at last follow up, whichever came first, assessed up to 60 months
|
Event Free Survival (EFS)
Time Frame: From date of treatment initiation until the date of event from any cause or patients censored at last follow up, whichever came first, assessed up to 60 months
|
Participants will be retrospectively followed forward in time from the date of initiation of treatment till occurrence of an event from any cause (tumor progression, relapse) or death, an expected average of 5 years
|
From date of treatment initiation until the date of event from any cause or patients censored at last follow up, whichever came first, assessed up to 60 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 7, 2020
Primary Completion (Actual)
December 16, 2020
Study Completion (Actual)
December 16, 2020
Study Registration Dates
First Submitted
March 5, 2020
First Submitted That Met QC Criteria
March 5, 2020
First Posted (Actual)
March 9, 2020
Study Record Updates
Last Update Posted (Actual)
December 17, 2020
Last Update Submitted That Met QC Criteria
December 16, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ESFT_Upp_Egypt
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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