A Study to Assess Programmed Death Ligand-1 (PD-L1) Expression in Cytological Versus Histological Lung Cancer Specimens

July 22, 2019 updated by: Hoffmann-La Roche

A Non-Interventional Multinational Study to Assess PD-L1 Expression in Cytological Versus Histological Non-Small Cell or Small Cell Lung Cancer Specimens

The primary purpose of this non-interventional, multinational study is to assess the feasibility of assessing PD-L1 protein expression on cytological samples as a surrogate for histological samples obtained from participants with any stage of non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
184

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
      • Praha 2, Czechia, 128 08
        • Vseobecna fakultni nemocnice v Praze; I. klinika tuberkulozy a respiracnich nemoci
  • Germany
      • Göttingen, Germany, 37075
        • Universitätsklinikum Göttingen, Institut für Pathologie
  • Poland
      • Warszawa, Poland, 01-138
        • Instytut Gruźlicy i Chorób Płuc, I Klinika Chorób Płuc
  • Spain
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz; Servicio de Anatomia Patologica
      • Madrid, Spain, 28050
        • HOSPITAL DE MADRID NORTE SANCHINARRO- C. INTEGRAL ONC. CLARA CAMPAL; Servicio Anatomia Patologica
    • LA Coruña
      • A Coruña, LA Coruña, Spain, 15006
        • Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Anatomía Patológica
  • Switzerland
      • Basel, Switzerland, 4031
        • Universitätsspital Basel; Pathologie
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
        • Aberdeen Royal Infirmary

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants with any stage of NSCLC or SCLC who have cytological and histological samples available.

Description

Inclusion Criteria:

  • Samples must have been collected in a manner that is compliant with local ethics committee guidance
  • Samples must originate from participants diagnosed with NSCLC or SCLC
  • Participants must have a pair of at least one cytological and one histological specimen that: Both originate from inside the thorax or from the same ex-thoracic site; Are confirmed to have been collected within a window no more than 6 weeks apart from each other; and are in compliance with the protocol defined sample requirements for histological and cytological specimens

Exclusion Criteria:

  • Immune checkpoint inhibitor therapy from 4 weeks prior to collection of the first tumor sample until collection of the second matched sample

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Cytological and Histological Samples
Cytological and histological specimens that meet the eligibility criteria will be analyzed only from those participants who have consented to biomarker research, according to local regulations and ethical guidelines. Cytological samples may originate from fine needle aspirations. Pleural effusions or bronchial cytology samples (brushings and washings) may be allowed. Histological samples may originate from core needle biopsies, bronchial biopsies (thoracoscopy or mediastinoscopy) or surgical tissue resections.
Diagnostic test: PD-L1 Immunocytochemistry (ICC)
PD-L1 expression in the cytological specimens will be assessed using different antibodies.
Diagnostic test: PD-L1 Immunohistochemistry (IHC)
PD-L1 expression in the histological specimens will be assessed using different antibodies.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of Total Tumor Cells (TC) That Display Discernible PD-L1 Staining of any Intensity in Histological and Cytological Samples As Assessed Using PD-L1 IHC/ICC Assay
Time Frame: approximately 12 months
approximately 12 months
Percentage of Total TC Within ten High-Power Fields (HPF) That Display Discernible PD-L1 Staining of any Intensity in Histological and Cytological Samples As Assessed Using PD-L1 IHC/ICC Assay
Time Frame: approximately 12 months
approximately 12 months
Percentage of Total Tumor Area That Contain Tumor-Infiltrating Immune Cells of any Discernible PD-L1 Staining of any Intensity in Histological Samples As Assessed Using PD-L1 IHC Assay
Time Frame: approximately 12 months
approximately 12 months
Percentage of Total Immune Cells That Display Discernible PD-L1 Staining of any Intensity in Cytological Samples As Assessed Using PD-L1 ICC Assay
Time Frame: approximately 12 months
approximately 12 months
Percentage of Total Immune Cells Within ten HPF That Display Discernible PD-L1 Staining of any Intensity in Histological and Cytological Samples As Assessed Using PD-L1 IHC/ICC Assay
Time Frame: approximately 12 months
approximately 12 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 3, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 8, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 6, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 23, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MO29978

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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