Localized Osteosarcoma in Upper Egypt: A Clinical Prediction Model

Completed

• Conditions: Bone Neoplasms

• Registration Number: NCT03839095
• Lead Sponsor: Assiut University

Brief Summary

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.

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 Timeline

• Study Start: 2018-01-01
• Primary Completion: 2018-07-20
• Study Completion: 2018-08-25
• Status Verified: 2019-02
• Study First Submitted: 2019-02-09
• Study First Submitted QC: 2019-02-11
• Last Update Submitted: 2019-02-11
• Study First Posted: 2019-02-15
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	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	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
Metastasis-Free survival (MFS)	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	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

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt