Malignant Pediatric Soft Tissue & Bone Tumors of the Extremities: A Retrospective Study

January 7, 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 soft tissue & bone tumors involving the extremities & treatment outcomes in these patients.

Study Overview

Status

Completed

Conditions

Detailed Description

Background:

Sarcomas are a heterogeneous group of rare tumors that arise predominantly from the embryonic mesoderm. The various sarcomas include bone sarcomas (osteosarcomas and chondrosarcomas), Ewing's sarcomas, peripheral primitive neuroectodermal tumors, and soft tissue sarcomas.

Soft tissue sarcomas account for approximately 1% of adult malignancies and 7% to 15% of pediatric malignancies. Rhabdomyosarcoma is the most common soft tissue sarcoma of childhood.

There is some confusion within segments of the medical community as to the precise meaning of "soft tissue." The soft tissue of the human body includes all extraskeletal tissue that is neither epithelial, hematopoietic (marrow derived blood elements), nor parenchymal (constituent of a visceral organ). The nervous system is divided such that neither the glial nor the central neuronal elements are considered to be soft tissue, though by convention the peripheral nervous system is. In sum, the soft tissues consist of adipose tissue, fibrous tissue, musculature, vascular structures, and peripheral nerves.

About 50% to 60% of sarcomas occur in the extremities, and although they are rare, they are responsible for more deaths than testicular cancer, Hodgkin's disease, and thyroid cancer combined.

Patients & Methods:

From January 2000 till December 2015, retrieval & analysis of the medical records of pediatric patients with soft tissue & bone tumors involving the extremities will be made at the pediatric oncology department, South Egypt Cancer Institute which represents the largest referral center in Upper Egypt. These data will be categorized according to demographic characteristics, clinico-pathologic features, treatment modalities received, and outcomes of treatments in these patients.

Study Type

Observational

Enrollment (Actual)

163

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

  • Egypt
      • Assiut, Egypt, 71515
        • Assiut University

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 18 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 bone & soft tissue neoplasms involving the extremities, 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 bone & soft tissue neoplasms involving the extremities.

Exclusion Criteria:

  • Patients whose age more than 19 years.
  • Patients diagnosed with bone & soft tissue neoplasms not involving the extremities.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: Participants will be retrospectively followed forward in time from the date of initiation of treatment till the primary completion date of the study, an expected average of 5 years
Time from the date of initiation of treatment until death from any cause
Participants will be retrospectively followed forward in time from the date of initiation of treatment till the primary completion date of the study, an expected average of 5 years
Event Free Survival (EFS)
Time Frame: Participants will be retrospectively followed forward in time from the date of initiation of treatment till the primary completion date of the study, an expected average of 5 years
Time from the date of initiation of treatment until disease progression, or death for any reason.
Participants will be retrospectively followed forward in time from the date of initiation of treatment till the primary completion date of the study, an expected average of 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2016

Primary Completion (Actual)

November 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

September 21, 2015

First Submitted That Met QC Criteria

September 21, 2015

First Posted (Estimate)

September 23, 2015

Study Record Updates

Last Update Posted (Actual)

January 10, 2020

Last Update Submitted That Met QC Criteria

January 7, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ped Malig Extremities
  • IRB00008718 (Registry Identifier: Assiut University)

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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