NCT04300179

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 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

First Submitted

Initial submission to the registry

March 5, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 9, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

July 7, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2020

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

5 months

First QC Date

March 5, 2020

Last Update Submit

December 16, 2020

Conditions

Keywords

Ewing's sarcoma (ES)Peripheral primitive neuroectodermal tumor (PNET)

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    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

Eligibility Criteria

AgeUp to 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Patients whose age less than 19 years. Patients diagnosed with Ewing Sarcoma Family of Tumors (ESFT).

You may not qualify if:

  • Patients whose age more than 19 years. Patients diagnosed with other bone \& soft tissue neoplasms.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Egypt Cancer Institute

Asyut, Egypt

Location

MeSH Terms

Conditions

Soft Tissue NeoplasmsBone NeoplasmsNeoplasmsSarcoma, EwingNeuroectodermal Tumors, Primitive, Peripheral

Condition Hierarchy (Ancestors)

Neoplasms by SiteBone DiseasesMusculoskeletal DiseasesOsteosarcomaNeoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeSarcomaNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Pediatric Oncology

Study Record Dates

First Submitted

March 5, 2020

First Posted

March 9, 2020

Study Start

July 7, 2020

Primary Completion

December 16, 2020

Study Completion

December 16, 2020

Last Updated

December 17, 2020

Record last verified: 2020-12

Locations