Prognostic Value of PD-L1 in NSCLC
The Prognostic Value of the Expression of Programmed Death Ligand 1 (PD-L1) in Early Stage Non-small-cell Lung Cancer
1 other identifier
observational
350
0 countries
N/A
Brief Summary
This is an observational retrospective study. The primary objective is to investigate the expression and potential prognostic role of Programmed Death Ligand 1 (PD-L1) in tumor samples from 350 patients with early stage treatment-naive non-small-cell lung cancer (NSCLC). Tissue samples were embedded in a tissue microarray. PD-L1 will be studied by immunohistochemistry using the SP263 antibody. Stained samples will be evaluated independently by two operators. A tumor will be defined as positive when = or \>50% of tumor cells express the ligand. The investigators will investigate the relationship between PD-L1 protein expression and overall survival and other clinical characteristics with appropriate statistical methods.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2017
Shorter than P25 for all trials
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
First Submitted
Initial submission to the registry
March 3, 2017
CompletedStudy Start
First participant enrolled
March 3, 2017
CompletedFirst Posted
Study publicly available on registry
March 14, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2017
CompletedMarch 14, 2017
March 1, 2017
27 days
March 3, 2017
March 8, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Expression
The study will investigate PD-L1 protein expression by immunohistochemistry in tumor samples from early stage NSCLC
15 days
Prognostic value
The correlation between PD-L1 protein expression by immunohistochemistry and overall survival will be studied
15 days
Interventions
Samples will be stained using the SP263 antibody clone against PD-L1
Eligibility Criteria
350 patients with stagi I-III NSCLC
You may qualify if:
- Early stage treatment-naive NSCLC
You may not qualify if:
- Received any pre-surgical treatment
- no OS data available
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
Formalin fixed paraffin embedded specimen were collected from 350 patients who underwent surgical resection of early stage NSCLC. Tumors samples were included in a tissue microarray.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2017
First Posted
March 14, 2017
Study Start
March 3, 2017
Primary Completion
March 30, 2017
Study Completion
April 15, 2017
Last Updated
March 14, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share