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Trial record 3 of 4295 for:    bone tumors AND NOT metastatic

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

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ClinicalTrials.gov Identifier: NCT02557243
Recruitment Status : Recruiting
First Posted : September 23, 2015
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed Mohammed Morsy, MD, Assiut University

Brief Summary:
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.

Condition or disease
Soft Tissue Neoplasms Bone Neoplasms

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.


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Study Type : Observational
Estimated Enrollment : 260 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Malignant Pediatric Soft Tissue & Bone Tumors of the Extremities: A Retrospective Study
Study Start Date : January 2016
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Cancer




Primary Outcome Measures :
  1. 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

  2. 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.



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557243


Locations
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Egypt
Assiut University Recruiting
Assiut, Egypt, 71515
Contact: Ahmed M. Morsy, MD    +2 01003314522    ahmedmohammed7829@yahoo.com   
Principal Investigator: Ahmed M. Morsy, MD         
Principal Investigator: Khalid M. Rezk, MD         
Principal Investigator: Badawy M. Ahmed, MD         
Principal Investigator: Ameer M. Abuelgheet, MD         
Principal Investigator: Marwa I. Abdelgawad, MD         
Sponsors and Collaborators
Assiut University

Publications:
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Responsible Party: Ahmed Mohammed Morsy, MD, Lecturer, Pediatric Oncology Department, Assiut University
ClinicalTrials.gov Identifier: NCT02557243     History of Changes
Other Study ID Numbers: Ped Malig Extremities
IRB00008718 ( Registry Identifier: Assiut University )
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019

Keywords provided by Ahmed Mohammed Morsy, MD, Assiut University:
Childhood Cancer
Soft Tissue Tumors
Bone Tumors
Extremity Tumor
Pediatric Oncology

Additional relevant MeSH terms:
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Neoplasms
Bone Neoplasms
Soft Tissue Neoplasms
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases