PD-L1 Expression in Advanced Osteosarcoma
The Expression of Programmed Death Ligand-1 (PD-L1) on Advanced Osteosarcoma Tissue and Its Influence on Prognosis
1 other identifier
observational
50
1 country
1
Brief Summary
The expression level of PD-L1 on tumor cells is a pivotal point which might have some influence on prognosis, especially for those who might use PD-1 or PD-L1 antibody for treatment. The aim of this study is to detect the expression of PD-1 on advaced osteosarcoma patient who might use these antibodies for treatment. All those specimen should be taken by pathologist and confirmed with high tumor cellularity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2018
CompletedFirst Submitted
Initial submission to the registry
June 10, 2018
CompletedFirst Posted
Study publicly available on registry
July 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2020
CompletedAugust 1, 2018
July 1, 2018
1.6 years
June 10, 2018
July 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PD-L1 expression level
all those specimens will be tested for expression level,Tumors with ≥50% cells showing positive membrane staining were considered to have high expression of PD-L1
2 months
Secondary Outcomes (2)
progression free survival
2 years
overall survival
5 years
Study Arms (1)
observation group
All these patients who have been tested will be observed for further treatment and been recorded for toxicity.
Interventions
patients will receive anti-PD-1/anti-PD-L1 antibody for further treatment
Eligibility Criteria
All those advanced osteosarcoma patients who intend to receive anti-PD-1/anti-PD-L1 therapy.
You may qualify if:
- diagnosis confirmed histologically and reviewed centrally;
- received surgery in Musculoskeletal Tumor Center of Peking University People's Hospital with appropriate sample for immunohistochemical staining;
- progressing upon prior treatment (completed \>4 weeks before trial entry) consisted of standard high-grade osteosarcoma chemotherapy agents including doxorubicin, cisplatin, high-dose methotrexate, and ifosfamide; metastatic relapsed and unresectable progressive disease (PD);
- having measurable lesion according to RECIST 1.1;
- Eastern Cooperative Oncology Group performance status 0-1 with a life expectancy \>3 months;
- intend to receive anti-PD-1/anti-PD-L1 antibody for therapy.
You may not qualify if:
- fail to be followed up regularly.
- sample disqualification.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Musculoskeletal Tumor Center of Peking University People's Hospital
Beijing, Beijing Municipality, 100, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2018
First Posted
July 11, 2018
Study Start
June 1, 2018
Primary Completion
December 31, 2019
Study Completion
February 15, 2020
Last Updated
August 1, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share