Localized Osteosarcoma in Upper Egypt: A Clinical Prediction Model

• ClinicalTrials.gov Identifier: NCT03839095
• Recruitment Status: Completed
• First Posted: February 15, 2019
• Last Update Posted: February 15, 2019
• Sponsor: Assiut University
• Information provided by (Responsible Party): Ahmed Mohammed Morsy, MD, Assiut University

Study Description

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.

Condition or disease
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 Design

• Study Type: Observational
• Actual Enrollment: 30 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Localized Osteosarcoma of Extremities: Developing a Clinical Prediction Model From a Country With Limited Resources
• Actual Study Start Date: January 1, 2018
• Actual Primary Completion Date: July 20, 2018
• Actual Study Completion Date: August 25, 2018

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Overall survival (OS) [ Time Frame: 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
2. Metastasis-Free survival (MFS) [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: up to 19 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

Criteria

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 .

Contacts and Locations

Locations

Egypt

Assiut University

Assiut, Egypt, 71515

Sponsors and Collaborators

Assiut University

More Information

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.

• Responsible Party: Ahmed Mohammed Morsy, MD, Lecturer, Pediatric Oncology Department, Assiut University
• ClinicalTrials.gov Identifier: NCT03839095
• Other Study ID Numbers: IRB_Os_Pred_Mod
• First Posted: February 15, 2019
• Last Update Posted: February 15, 2019
• Last Verified: February 2019

Keywords provided by Ahmed Mohammed Morsy, MD, Assiut University:

Nonmetastatic Osteosarcoma; Pediatric Cancer; Limb Salvage; Prediction Model

Additional relevant MeSH terms:

Osteosarcoma; Bone Neoplasms; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Neoplasms by Site; Bone Diseases; Musculoskeletal Diseases