Soluble B7-H3 as a Biomarker for Osteosarcoma

Recruiting

• Conditions: Progression; Biomarker; Osteosarcoma; Surveillance

• Registration Number: NCT05942456
• Lead Sponsor: Peking University People's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-05
• Study First Submitted: 2023-07-05
• Study First Submitted QC: 2023-07-05
• Study First Posted: 2023-07-12
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-11
• Last Update Posted: 2024-05-14
• Primary Completion: 2024-07-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
correlation of quantity of Protein B7-H3 Expression with clinical evaluation	6 months	Clinical evaluation according to RECIST 1.1

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China