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

NCT02855281 | Completed Results

• 1 other identifier: WI_16-233
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Neoplasms

Outcome Measures

Primary Outcomes (3)

• PD-L1 Prevalence IHC

  Number/prevalence of PD-L1-positive patients according to immunohistochemistry (IHC) of pleural biopsy.

  At baseline

• PD-L1 Prevalence ICC

  Number/prevalence of PD-L1-positive patients according to immunocytochemistry (ICC) of pleural aspirate

  At baseline

• PD-L1 Detection in Pleural Effusion Based on All Cases With Successful PD-L1 Analysis

  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.

  At baseline

Secondary Outcomes (2)

• PD-L1 Detection in Pleural Effusion Based on All Cases With Indication for PD-L1 Analysis

  At baseline

• Tumor Cell Detection in Pleural Effusion

  At baseline

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wissenschaftliches Institut Bethanien e.V: lead
• Merck Sharp & Dohme LLC: collaborator
• Heinrich-Heine University, Duesseldorf: collaborator

Study Sites (1)

Wissenschaftliches Institut Bethanien e. V.

Solingen, North Rhine-Westphalia, 42699, Germany

Location

Related Publications (1)

• Hagmeyer L, Schafer S, Engels M, Pietzke-Calcagnile A, Treml M, Herkenrath SD, Heldwein M, Hekmat K, Matthes S, Scheel A, Wolf J, Buttner R, Randerath W. High sensitivity of PD-L1 analysis from pleural effusion in nonsmall cell lung cancer. ERJ Open Res. 2021 Mar 22;7(1):00787-2020. doi: 10.1183/23120541.00787-2020. eCollection 2021 Jan.

  PMID: 33778051 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The fact that the PE did not always yield enough material for a comprehensive immunocytochemistry evaluation including PD-L1 analysis, constitutes an important limitation, in part leading to inconclusive results regarding malignancy. This may be due to a low rate of cells scaling off from the pleural lesion and/or a low rate of migration of tumor cells into the pleural fluid.

Results Point of Contact

• Title: Dr. Lars Hagmeyer
• Organization: Hospital Bethanien Solingen, Clinic of Pneumology and Allergology, Center for Sleep Medicine and Respiratory Care, Solingen, Germany

institut@klinik-bethanien.de

0212636004

Study Officials

• Winfried J Randerath, Prof. Dr.

  Wissenschaftliches Institut Bethanien e.V

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 4, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 5, 2021
• Results First Posted: March 5, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)