Soluble B7-H3 as a Biomarker for Osteosarcoma

May 11, 2024 updated by: Xie Lu, Peking University People's Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100044
        • Recruiting
        • Peking University People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation of quantity of Protein B7-H3 Expression with histological responses
Time Frame: 6 months
Histological responses according to Huvos Grade
6 months
correlation of quantity of Protein B7-H3 Expression with event-free survival
Time Frame: 2 years
event-free survival calculated from starting systemic therapy to any tumor-related events for progression
2 years
correlation of quantity of Protein B7-H3 Expression with overall survival
Time Frame: 5 years
overall survival calculated from starting systemic therapy to death
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Collaborators

Shanghai Hansen Biopharmaceutical Technology Co., Ltd
MEDx Translational Medicine Co., Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

July 5, 2023

First Submitted That Met QC Criteria

July 5, 2023

First Posted (Actual)

July 12, 2023

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 11, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PKUPH-sarcoma 16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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