BiomarkerNCT05942456
Soluble B7-H3 as a Biomarker for Osteosarcoma
An observational study of Biomarker and Progression, run by Peking University People's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Biomarker, Progression, Osteosarcoma
- What is being tested?
- ELISA: enzyme-linked immunosorbent assay
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 5 Jun 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Initial treated osteosarcoma patients in PKUPH and later would recieve definitive surgery in PKUPH with complete clinical materials.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Lu Xie, M.D., +86-13401044719, xie.lu@hotmail.com
About this study
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
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
- Being tested
- ELISA: enzyme-linked immunosorbent assay
- Keywords
- sB7-H3, osteosarcoma, biomarker, prognosis, clinical evaluation
- Medical subject headings
- Disease Progression, Osteosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELISA: enzyme-linked immunosorbent assayDiagnostic test
enzyme-linked immunosorbent assay
| Study group | Role | What they receive |
|---|---|---|
| sB7-H3 of treatment-naive osteosarcoma patients | Before delivering neoadjuvant chemotherapy, using ELISA to test the protein expression of sB7-H3 of Peripheral Blood Receives: 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 Receives: Diagnostic Test: ELISA: enzyme-linked immunosorbent assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation of quantity of Protein B7-H3 Expression with clinical evaluation
Clinical evaluation according to RECIST 1.1
Measured: 6 months
Secondary outcomes (3)
correlation of quantity of Protein B7-H3 Expression with histological responses
Histological responses according to Huvos Grade
Measured: 6 months
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
Measured: 2 years
correlation of quantity of Protein B7-H3 Expression with overall survival
overall survival calculated from starting systemic therapy to death
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start5 Jun 2023
- Primary completion1 Jul 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BiomarkerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xie Lu, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942456
- Sponsor's protocol ID
- PKUPH-sarcoma 16
- Status last verified
- May 2024
- First submitted
- 5 Jul 2023
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30123093Xie 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.
PubMed 36519392
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05942456
- Acronym / sponsor ID
- PKUPH-sarcoma 16
- Conditions
- Biomarker, Progression, Osteosarcoma, Surveillance
- Keywords
- sB7-H3, osteosarcoma, biomarker, prognosis, clinical evaluation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sB7-H3 of treatment-naive osteosarcoma patients | – | Diagnostic Test: ELISA: enzyme-linked immunosorbent assayBefore delivering neoadjuvant chemotherapy, using ELISA to test the protein expression of sB7-H3 of Peripheral Blood |
| sB7-H3 after neoadjuvant chemotherapy for osteosarcoma patients | – | Diagnostic Test: ELISA: enzyme-linked immunosorbent assayAfter neoadjuvant chemotherapy and before definitive surgery, using ELISA to test the protein expression of sB7-H3 of Peripheral Blood |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Initial treated osteosarcoma patients in PKUPH and later would recieve definitive surgery in PKUPH with complete clinical materials.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELISA: enzyme-linked immunosorbent assayenzyme-linked immunosorbent assay | Diagnostic test | sB7-H3 after neoadjuvant chemotherapy for osteosarcoma patients, sB7-H3 of treatment-naive osteosarcoma patients |
Primary outcome
correlation of quantity of Protein B7-H3 Expression with clinical evaluation
Time frame: 6 months
Clinical evaluation according to RECIST 1.1
3 secondary outcomes
correlation of quantity of Protein B7-H3 Expression with histological responses
Time frame: 6 months
correlation of quantity of Protein B7-H3 Expression with event-free survival
Time frame: 2 years
correlation of quantity of Protein B7-H3 Expression with overall survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Background: PubMed 30123093Wang 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.
- Background: PubMed 36519392Xie 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biomarker and Progression, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lu Xie, M.D. (+86-13401044719, xie.lu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation of quantity of Protein B7-H3 Expression with clinical evaluation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05942456, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.