Soluble B7-H3 as a Biomarker for Osteosarcoma

Study Overview
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Brief Summary
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Increasing data has indicated an association between increased soluble B7-H3 (sB7-H3) levels and unfavorable prognosis in patients with malignancies. However, the level of sB7-H3 and its clinical significance in osteosarcoma are not well known. In this present study, we investigated whether sB7-H3 levels in serum could be as a biomarker for osteosarcoma treatment.

Official Title
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An Exploratory Research of Soluble B7-H3 Expression in Peripheral Blood as a Biomarker to Monitor Therapeutic Effect of Systemic Treatment for Osteosarcoma

Conditions
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Biomarker, Progression, Osteosarcoma, Surveillance

Intervention / Treatment
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* Diagnostic Test: ELISA: enzyme-linked immunosorbent assay


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: High Grade osteosarcoma verified with pathologic diagnosis. systemic treatment-naive before the first time Blood drawing. ECOG 0 or 1 and all the other imagings indicate that patients could tolerate standard PKUPH-OS-02 protocol neoadjuvant chemotherapy. All radiographs are complete for clinical evaluation. Exclusion Criteria: Patients who Can't tolerate blood drawing. Patients without complete medical records in PKUPH system. Patients who can't tolerate PKUPH-OS-02 neoadjuvant chemotherapy. other conditions that investigators think are not suitable for this study.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| sB7-H3 of treatment-naive osteosarcoma patients<br>Before delivering neoadjuvant chemotherapy, using ELISA to test the protein expression of sB7-H3 of Peripheral Blood | Diagnostic Test: ELISA: enzyme-linked immunosorbent assay<br>* enzyme-linked immunosorbent assay<br>|
| sB7-H3 after neoadjuvant chemotherapy for osteosarcoma patients<br>After neoadjuvant chemotherapy and before definitive surgery, using ELISA to test the protein expression of sB7-H3 of Peripheral Blood | Diagnostic Test: ELISA: enzyme-linked immunosorbent assay<br>* enzyme-linked immunosorbent assay<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation of quantity of Protein B7-H3 Expression with clinical evaluation | Clinical evaluation according to RECIST 1.1 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation of quantity of Protein B7-H3 Expression with histological responses | Histological responses according to Huvos Grade | 6 months | 
| correlation of quantity of Protein B7-H3 Expression with event-free survival | event-free survival calculated from starting systemic therapy to any tumor-related events for progression | 2 years | 
| correlation of quantity of Protein B7-H3 Expression with overall survival | overall survival calculated from starting systemic therapy to death | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sB7-H3, osteosarcoma, biomarker, prognosis, clinical evaluation