Localized Osteosarcoma in Upper Egypt: A Clinical Prediction Model

Localized Osteosarcoma of Extremities: Developing a Clinical Prediction Model From a Country With Limited Resources

To assess survival outcome of pediatric patients with localized osteosarcoma of the extremities in Upper Egypt, identify factors of prognostic significance for survival, and to determine factors predictive of surgical methods employed in these patients, and developing a clinical model for risk prediction.

Study Overview

• Status: Completed
• Conditions: Bone Neoplasms

Detailed Description

Background Osteosarcoma is the most common of all primary malignant bone tumors. Accounting for about 2.6% of all pediatric neoplasms, it predominantly occurs in the extremities, with a peak incidence in the second decade of life.

In Upper Egypt, we have a higher proportion of the population in underdeveloped communities with limited access to medical care so the patients usually seek medical advice at advanced stage leading to a higher prevalence of metastatic disease at initial presentation, as well as a greater proportion of larger tumor size that more likely to be associated with potential adverse risk criteria prior to surgery.

A previous study from Upper Egypt showed that a metastatic disease at diagnosis was independently correlated to a dismal outcome. Since the effect of many other factors of prognostic significance, such as, gender, age, tumor location and response to chemotherapy may have been mitigated by the large effect of the metastatic disease on the prognosis; So, here, we will analyze the data of 30 patients with non-metastatic osteosarcoma of the extremities, to determine prognostic factors associated with survival, and also to develop a model for a better prediction of factors correlated to that a certain surgical approach was employed in these patients based on their baseline clinical data and the tumor response to chemotherapy.

Patients & Methods We will carry out a retrospective analysis of data assembled from medical records of 30 pediatric patients with a histologically-verified non-metastatic osteosarcoma of the extremities treated at South Egypt Cancer Institute with a unified chemotherapy protocol between January 2001 and December 2015. These data will be categorized according to demographic data, clinical characteristics, tumor response to chemotherapy, and surgical methods employed in these patients. Prognostic factors will be determined using univariable and multivariable methods. A predictive model for surgical outcomes in these patients based on the baseline clinical factors, and their tumor response to chemotherapy will be developed.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71515
    • Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

30 pediatric patients with a histologically-verified non-metastatic osteosarcoma of the extremities treated at South Egypt Cancer Institute with a unified chemotherapy protocol between January 2001 and December 2015.

Description

Inclusion Criteria:

• Patients whose age less than 19 years.
• Patients diagnosed with verified osteosarcoma involving the extremities.

Exclusion Criteria:

• Patients whose age more than 19 years.
• Non-extremities Osteosarcoma .

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)	Participants will be retrospectively followed forward in time from the date of initiation of treatment till death from any cause, an expected average of 5 years	From date of treatment initiation until the date of death from any cause or patients censored at last follow up, whichever came first, assessed up to 60 months
Metastasis-Free survival (MFS)	Participants will be retrospectively followed forward in time from the date of initiation of treatment till the occurrence of systemic recurrence, an expected average of 5 years	From date of treatment initiation until the date of first documented systemic recurrence or patients censored at last follow up, whichever came first, assessed up to 60 months

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Morsy AM, Abdelgawad MI, Ahmed BM, Rezk KM, Aboelgheit AM, Ramadan IK, Kamel HEM, Fouad DM, Herdan RA, Shabaan SH, Eltyb HA. Pediatric Osteosarcoma of Extremities: A 15-year Experience From a Tertiary Care Cancer Center in Upper Egypt. J Pediatr Hematol Oncol. 2019 Aug;41(6):e371-e383. doi: 10.1097/MPH.0000000000001407.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): July 20, 2018
• Study Completion (Actual): August 25, 2018

Study Registration Dates

• First Submitted: February 9, 2019
• First Submitted That Met QC Criteria: February 11, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): February 15, 2019
• Last Update Submitted That Met QC Criteria: February 11, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Pediatric Cancer; Prediction Model; Limb Salvage; Nonmetastatic Osteosarcoma
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Musculoskeletal Diseases; Bone Diseases; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Sarcoma; Bone Neoplasms; Osteosarcoma
• Other Study ID Numbers: IRB_Os_Pred_Mod