Localized Osteosarcoma in Upper Egypt: A Clinical Prediction Model

Bone Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03839095
• Other study ID #: IRB_Os_Pred_Mod
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: August 25, 2018

Study information

• Verified date: February 2019
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 25, 2018
• Est. primary completion date: July 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 19 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Bone Neoplasms
• Osteosarcoma

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 (1)

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 Jan 8. doi: 10.1097/MPH.0000000000001407. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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