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Sensitivity of PDL-1-analysis From Pleural Effusion in Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT02855281
Recruitment Status : Completed
First Posted : August 4, 2016
Results First Posted : March 5, 2021
Last Update Posted : March 5, 2021
Sponsor:
Collaborators:
Merck Sharp & Dohme LLC
Institute of Pathology, University Clinic Düsseldorf
Information provided by (Responsible Party):
Wissenschaftliches Institut Bethanien e.V

Study Description
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Brief Summary:
This is a prospective diagnostic pilot study to create hypotheses regarding immunocytochemistry (ICC) PD-L1 analysis of pleural effusions in NSCLC patients as compared to the reference standard of PD-L1 immunohistochemistry (IHC). This comparison will be done to assess sensitivity and specificity of PD-L1 detection by ICC in pleural effusions.

Condition or disease
Lung Neoplasms

Study Design
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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Sensitivity of PDL-1-analysis From Pleural Effusion in Non-small Cell Lung Cancer
Actual Study Start Date : October 2016
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Groups and Cohorts
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Group/Cohort
NSCLC with pleural effusion
The population for selection of potential study participants is comprised of clinical routine patients presenting with (suspected malignant) pleural effusion. These patients must have an indication for pleural puncture. The cause and nature of the pleural effusion at this time point will be unknown in many cases. To establish this, further diagnostic procedures are required. Only patients with confirmed diagnosis of non-small cell lung cancer will be included in the data analysis.


Outcome Measures
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Primary Outcome Measures :
  1. PD-L1 Prevalence IHC [ Time Frame: At baseline ]
    Number/prevalence of PD-L1-positive patients according to immunohistochemistry (IHC) of pleural biopsy.

  2. PD-L1 Prevalence ICC [ Time Frame: At baseline ]
    Number/prevalence of PD-L1-positive patients according to immunocytochemistry (ICC) of pleural aspirate

  3. PD-L1 Detection in Pleural Effusion Based on All Cases With Successful PD-L1 Analysis [ Time Frame: At baseline ]

    Based on all cases where PD-L1 analysis was indicated and sucessful (i.e. giving definite results), the immunocytochemistry analysis of PE was compared with the immunohistochemistry analysis of pleural tissue.Two different alternatives were calculated:

    • PD-L1 expression with a TPS ≥50% was defined as PD-L1-positive.
    • PD-L1 expression with a TPS ≥1% was defined as PD-L1-positive.


Secondary Outcome Measures :
  1. PD-L1 Detection in Pleural Effusion Based on All Cases With Indication for PD-L1 Analysis [ Time Frame: At baseline ]

    Based on all cases where PD-L1 analysis was indicated, the immunocytochemistry analysis of PE was compared with the immunohistochemistry analysis of pleural tissue.Two different alternatives were calculated:

    • PD-L1 expression with a TPS ≥50% was defined as PD-L1-positive.
    • PD-L1 expression with a TPS ≥1% was defined as PD-L1-positive. In both instances, cases where PD-L1 analysis could not be performed were defined as negative.

  2. Tumor Cell Detection in Pleural Effusion [ Time Frame: At baseline ]
    Comparing the immunocytochemistry (ICC) analysis of pleural effusion concerning the detection of malignant tumor cells as compared to the immunohistochemistry analysis of pleural tissue. Seven cases of ICC analysis with inconclusive results were defined as negative.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The population for selection of potential study participants is comprised of clinical routine patients presenting with (suspected malignant) pleural effusion. These patients must have an indication for pleural puncture. The cause and nature of the pleural effusion at this time point will be unknown in many cases. To establish this, further diagnostic procedures are required. Only patients with confirmed diagnosis of non-small cell lung cancer will be included in the data analysis.

A patient in whom suspicion of pleural manifestation of lung cancer is not confirmed, will be considered a screening failure and thus excluded from the study.

Criteria

Inclusion Criteria:

  • Presence of malignant pleural effusion with indication for pleural puncture and thoracoscopy
  • Confirmed diagnosis of non-small cell lung cancer according to ERS guidelines
  • Written informed consent

Exclusion Criteria:

  • Pregnancy and/or lactation
  • Acute and life-threatening illness (instable angina pectoris, acute pulmonary arterial embolism, myocardial infarction, etc.)
  • Any contraindication to undergo thoracoscopy (e.g. anticoagulation therapy which cannot be discontinued for the procedure)
  • Any medical, psychological or other condition impairing the patient's ability to provide informed consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02855281


Locations
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Germany
Wissenschaftliches Institut Bethanien e. V.
Solingen, NRW, Germany, 42699
Sponsors and Collaborators
Wissenschaftliches Institut Bethanien e.V
Merck Sharp & Dohme LLC
Institute of Pathology, University Clinic Düsseldorf
Investigators
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Principal Investigator: Winfried J Randerath, Prof. Dr. Wissenschaftliches Institut Bethanien e.V
  Study Documents (Full-Text)

Documents provided by Wissenschaftliches Institut Bethanien e.V:
Study Protocol and Statistical Analysis Plan  [PDF] November 4, 2016

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Wissenschaftliches Institut Bethanien e.V
ClinicalTrials.gov Identifier: NCT02855281    
Other Study ID Numbers: WI_16-233
First Posted: August 4, 2016    Key Record Dates
Results First Posted: March 5, 2021
Last Update Posted: March 5, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Pleural Effusion
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pleural Diseases