Soft Tissue NeoplasmsNCT04300179
Ewing Sarcoma Family of Tumors (ESFT): A 15-year Experience From a Tertiary Care Cancer Center in Upper Egypt
An observational study of Soft Tissue Neoplasms and Bone Neoplasms, run by Assiut University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 19 years
- Conditions the study is for
- Soft Tissue Neoplasms, Bone Neoplasms, Neoplasms
- How many people
- 59 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Jul 2020to 16 Dec 2020
- 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 Up to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- Patients whose age less than 19 years. Patients diagnosed with Ewing Sarcoma Family of Tumors (ESFT).
Who cannot join
- Patients whose age more than 19 years. Patients diagnosed with other bone \& soft tissue neoplasms.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Soft Tissue Neoplasms, Bone Neoplasms, Neoplasms
- Keywords
- Ewing's sarcoma (ES), Peripheral primitive neuroectodermal tumor (PNET)
- Medical subject headings
- Soft Tissue Neoplasms, Bone Neoplasms, Neoplasms, Sarcoma, Ewing, Neuroectodermal Tumors, Primitive, Peripheral
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
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
Measured: 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)
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start7 Jul 2020
- Primary completion16 Dec 2020
- Study completion16 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue NeoplasmsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohammed Morsy, MD, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300179
- Sponsor's protocol ID
- ESFT_Upp_Egypt
- Status last verified
- Dec 2020
- First submitted
- 5 Mar 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ewing Sarcoma Family of Tumors (ESFT): A 15-year Experience From a Tertiary Care Cancer Center in Upper Egypt
- ClinicalTrials.gov ID
- NCT04300179
- Acronym / sponsor ID
- ESFT_Upp_Egypt
- Conditions
- Soft Tissue Neoplasms, Bone Neoplasms, Neoplasms
- Keywords
- Ewing's sarcoma (ES), Peripheral primitive neuroectodermal tumor (PNET)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 16 Dec 2020 (actual)
- Study completion
- 16 Dec 2020 (actual)
- First posted
- 9 Mar 2020 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (1 listed)
- Patients whose age less than 19 years. Patients diagnosed with Ewing Sarcoma Family of Tumors (ESFT).
Key exclusion criteria (1 listed)
- Patients whose age more than 19 years. Patients diagnosed with other bone \& soft tissue neoplasms.
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
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
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
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 17 Dec 2020.
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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 Soft Tissue Neoplasms and Bone Neoplasms, run by Assiut University 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 1 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 17 Dec 2020. 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?
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). 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 17 Dec 2020.