Soluble B7-H3 as a Biomarker for Osteosarcoma

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05942456

Enrollment

200

Registered

2023-07-12

Start date

2023-06-05

Completion date

2024-12-31

Last updated

2024-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biomarker, Osteosarcoma, Progression, Surveillance

Keywords

sB7-H3, osteosarcoma, biomarker, prognosis, clinical evaluation

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.

Interventions

DIAGNOSTIC_TESTELISA: enzyme-linked immunosorbent assay

enzyme-linked immunosorbent assay

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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

Countries

China

Contacts

Primary ContactLu Xie, M.D.

xie.lu@hotmail.com+86-13401044719

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026