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

Completed

• Conditions: Bone Neoplasms; Soft Tissue Neoplasms

• Registration Number: NCT02557243
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-09-21
• Study First Submitted QC: 2015-09-21
• Study First Posted: 2015-09-23
• Study Start: 2016-01
• Primary Completion: 2019-11
• Study Completion: 2019-12
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-07
• Last Update Posted: 2020-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	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
Event Free Survival (EFS)	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.

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt