Soluble B7-H3 as a Biomarker for Osteosarcoma

NCT05942456 | Recruiting

• 1 other identifier: PKUPH-sarcoma 16
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Biomarker; Progression; Osteosarcoma; Surveillance

Keywords

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

Outcome Measures

Primary Outcomes (1)

• correlation of quantity of Protein B7-H3 Expression with clinical evaluation

  Clinical evaluation according to RECIST 1.1

  6 months

Secondary Outcomes (3)

• correlation of quantity of Protein B7-H3 Expression with histological responses

  6 months

• correlation of quantity of Protein B7-H3 Expression with event-free survival

  2 years

• correlation of quantity of Protein B7-H3 Expression with overall survival

  5 years

Study Arms (2)

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

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

Interventions

ELISA: enzyme-linked immunosorbent assay DIAGNOSTIC_TEST

enzyme-linked immunosorbent assay

sB7-H3 after neoadjuvant chemotherapy for osteosarcoma patients; sB7-H3 of treatment-naive osteosarcoma patients

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Initial treated osteosarcoma patients in PKUPH and later would recieve definitive surgery in PKUPH with complete clinical materials.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Related 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.

  PMID: 30123093 BACKGROUND

• 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.

  PMID: 36519392 BACKGROUND

MeSH Terms

Conditions

Disease Progression; Osteosarcoma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Central Study Contacts

Lu Xie, M.D.

CONTACT

+86-13401044719; xie.lu@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Musculoskeletal Tumor Center

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 12, 2023
• Study Start: June 5, 2023
• Primary Completion: July 1, 2024
• Study Completion: December 31, 2024
• Last Updated: May 14, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)