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

Bone Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02557243
• Other study ID #: Ped Malig Extremities
• Secondary ID: IRB00008718
• Status: Completed
• Start date: January 2016
• Est. completion date: December 2019

Study information

• Verified date: January 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: December 2019
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Neoplasms
• Neoplasms
• Soft Tissue Neoplasms

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Bakotic BW, Borkowski P. Primary soft-tissue neoplasms of the foot: the clinicopathologic features of 401 cases. J Foot Ankle Surg. 2001 Jan-Feb;40(1):28-35. Review. — View Citation

Cormier JN, Pollock RE. Soft tissue sarcomas. CA Cancer J Clin. 2004 Mar-Apr;54(2):94-109. Review. — View Citation

Sondak VK. Difficult situations in sarcoma. Issue 2. Surg Oncol. 2000 Aug;9(2):47. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)	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
Primary	Event Free Survival (EFS)	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