Clinical trial NCT02557243: Malignant Pediatric Soft Tissue & Bone Tumors of the Extremities: A Retrospective Study
Official title: Malignant Pediatric Soft Tissue & Bone Tumors of the Extremities: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Soft Tissue Neoplasms
Bone Neoplasms
Keywords: Childhood Cancer
Soft Tissue Tumors
Bone Tumors
Extremity Tumor
Pediatric Oncology
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2015-09-23
Enrollment: 163
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: 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
measure: Event Free Survival (EFS)
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
citation: Bakotic, B. W. (2001).
citation: Cormier JN, Pollock RE. Soft tissue sarcomas. CA Cancer J Clin. 2004 Mar-Apr;54(2):94-109. doi: 10.3322/canjclin.54.2.94.
citation: Sondak, V. (2000).