Prognostic Value of PD-L1 in NSCLC

March 8, 2017 updated by: Fondazione Ricerca Traslazionale

The Prognostic Value of the Expression of Programmed Death Ligand 1 (PD-L1) in Early Stage Non-small-cell Lung Cancer

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.

Study Overview

Status

Unknown

Conditions

Carcinoma, Non-Small-Cell Lung

Intervention / Treatment

Other: immunohistochemistry

Study Type

Observational

Enrollment (Actual)

350

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

350 patients with stagi I-III NSCLC

Description

Inclusion Criteria:

Early stage treatment-naive NSCLC

Exclusion Criteria:

Received any pre-surgical treatment
no OS data available

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expression Time Frame: 15 days	The study will investigate PD-L1 protein expression by immunohistochemistry in tumor samples from early stage NSCLC	15 days
Prognostic value Time Frame: 15 days	The correlation between PD-L1 protein expression by immunohistochemistry and overall survival will be studied	15 days

Collaborators and Investigators

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

Sponsor

Fondazione Ricerca Traslazionale

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)

March 3, 2017

Primary Completion (ANTICIPATED)

March 30, 2017

Study Completion (ANTICIPATED)

April 15, 2017

Study Registration Dates

First Submitted

March 3, 2017

First Submitted That Met QC Criteria

March 8, 2017

First Posted (ACTUAL)

March 14, 2017

Study Record Updates

Last Update Posted (ACTUAL)