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NCT Number: NCT02855281

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

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.

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Key information

Conditions

Lung Neoplasms Lung Diseases Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wissenschaftliches Institut Bethanien e. V.

Solingen, North Rhine-Westphalia, 42699, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Wissenschaftliches Institut Bethanien e.V

Other

Collaborators

  • Heinrich-Heine University, Duesseldorf
  • Merck Sharp & Dohme LLC

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 4, 2016
Registry last updated
Mar 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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