Soluble B7-H3 as a Biomarker for Osteosarcoma

Osteosarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05942456
• Other study ID #: PKUPH-sarcoma 16
• Status: Recruiting
• Start date: June 5, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Peking University People's Hospital
• Contact: Lu Xie, M.D.
• Phone: +86-13401044719
• Email: xie.lu[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Biomarker
• Osteosarcoma
• Progression
• Surveillance

Intervention

Diagnostic Test:
• ELISA: enzyme-linked immunosorbent assay
enzyme-linked immunosorbent assay

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlation of quantity of Protein B7-H3 Expression with clinical evaluation	Clinical evaluation according to RECIST 1.1	6 months
Secondary	correlation of quantity of Protein B7-H3 Expression with histological responses	Histological responses according to Huvos Grade	6 months
Secondary	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
Secondary	correlation of quantity of Protein B7-H3 Expression with overall survival	overall survival calculated from starting systemic therapy to death	5 years