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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02557243
Other study ID # Ped Malig Extremities
Secondary ID IRB00008718
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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