Prognostic Value of PD-L1 in NSCLC | NCT03078959

Studies
Prognostic Value of PD-L1 in NSCLC

NCT03078959

Sponsor

Fondazione Ricerca Traslazionale

Status

Unknown status

Last Update Posted

Mar 14, 2017Actual

Enrollment

350Actual

Phase

Not provided

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

immunohistochemistry

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 3, 2017Actual

Primary Completion Date

Mar 30, 2017Estimated

Completion Date

Apr 15, 2017Estimated

First Submitted Date

Mar 3, 2017

First Submission Date that Met QC Criteria

Mar 8, 2017

First Posted Date

Mar 14, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2017

Last Update Posted Date

Mar 14, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

350Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
immunohistochemistry	Other	Samples will be stained using the SP263 antibody clone against PD-L1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Early stage treatment-naive NSCLC

Exclusion Criteria:

Received any pre-surgical treatment
no OS data available

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

350 patients with stagi I-III NSCLC

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007150	Immunohistochemistry

Ancestor Terms

ID	Term
D006651	Histocytochemistry
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided