Soluble B7-H3 as a Biomarker for Osteosarcoma
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| sB7-H3 of treatment-naive osteosarcoma patients Before delivering neoadjuvant chemotherapy, using ELISA to test the protein expression of sB7-H3 of Peripheral Blood |
Diagnostic Test: ELISA: enzyme-linked immunosorbent assay
enzyme-linked immunosorbent assay
|
| sB7-H3 after neoadjuvant chemotherapy for osteosarcoma patients 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
enzyme-linked immunosorbent assay
|
Outcome Measures
Primary Outcome Measures
- correlation of quantity of Protein B7-H3 Expression with clinical evaluation [6 months]
Clinical evaluation according to RECIST 1.1
Secondary Outcome Measures
- correlation of quantity of Protein B7-H3 Expression with histological responses [6 months]
Histological responses according to Huvos Grade
- correlation of quantity of Protein B7-H3 Expression with event-free survival [2 years]
event-free survival calculated from starting systemic therapy to any tumor-related events for progression
- correlation of quantity of Protein B7-H3 Expression with overall survival [5 years]
overall survival calculated from starting systemic therapy to death
Eligibility Criteria
Criteria
Inclusion Criteria:
-
High Grade osteosarcoma verified with pathologic diagnosis.
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systemic treatment-naive before the first time Blood drawing.
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ECOG 0 or 1 and all the other imagings indicate that patients could tolerate standard PKUPH-OS-02 protocol neoadjuvant chemotherapy.
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All radiographs are complete for clinical evaluation.
Exclusion Criteria:
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Patients who Can't tolerate blood drawing.
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Patients without complete medical records in PKUPH system.
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Patients who can't tolerate PKUPH-OS-02 neoadjuvant chemotherapy.
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other conditions that investigators think are not suitable for this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking University People's Hospital | Beijing | Beijing | China | 100044 |
Sponsors and Collaborators
- Peking University People's Hospital
- Shanghai Hansen Biopharmaceutical Technology Co., Ltd
- MEDx Translational Medicine Co., Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Wang L, Kang FB, Zhang GC, Wang J, Xie MF, Zhang YZ. Clinical significance of serum soluble B7-H3 in patients with osteosarcoma. Cancer Cell Int. 2018 Aug 13;18:115. doi: 10.1186/s12935-018-0614-z. eCollection 2018.
- Xie L, Chen C, Liang X, Xu J, Sun X, Sun K, Yang R, Tang X, Guo W. Expression and Clinical Significance of Various Checkpoint Molecules in Advanced Osteosarcoma: Possibilities for Novel Immunotherapy. Orthop Surg. 2023 Mar;15(3):829-838. doi: 10.1111/os.13620. Epub 2022 Dec 15.
- PKUPH-sarcoma 16