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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
| Heinrich-Heine University, Duesseldorf | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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:
| At baseline |
| Measure | Description | Time Frame |
|---|---|---|
| PD-L1 Detection in Pleural Effusion Based on All Cases With Indication for PD-L1 Analysis | 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:
|
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Winfried J Randerath, Prof. Dr. | Wissenschaftliches Institut Bethanien e.V | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wissenschaftliches Institut Bethanien e. V. | Solingen | North Rhine-Westphalia | 42699 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33778051 | Derived | 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. |
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Clinical routine patients presenting with (suspected malignant) pleural effusion and indication for pleural puncture were considered for enrollment. Patients with confirmed malignancy of pleural effusion were actually enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Malignant Pleural Effusion | Patients with confirmed malignant pleural effusion |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
patients with confirmed diagnosis of non-small cell lung cancer
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| ID | Title | Description |
|---|---|---|
| BG000 | Malignant Pleural Effusion | patients with confirmed malignant pleural effusion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | PD-L1 Prevalence IHC | Number/prevalence of PD-L1-positive patients according to immunohistochemistry (IHC) of pleural biopsy. | Thoracoscopy was performed in all fifty patients. PD-L1 analysis of pleural tissue was indicated in all samples with evidence of tumor cells (n=40), excluding cases with small-cell lung cancer (n=2). Mainly due to insufficient sample material (low tumor cell count) (n=3), PD-L1 analysis could actually be performed in 35 pleural tissue cases. | Posted | Count of Participants | Participants | At baseline |
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lars Hagmeyer | Hospital Bethanien Solingen, Clinic of Pneumology and Allergology, Center for Sleep Medicine and Respiratory Care, Solingen, Germany | 0212636004 | institut@klinik-bethanien.de |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 4, 2016 | Feb 12, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| At baseline |
| Tumor Cell Detection in Pleural Effusion | 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. | At baseline |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BMI | Median | Inter-Quartile Range | kg/m2 |
|
| smoking status | Count of Participants | Participants |
|
| Histology Type | Count of Participants | Participants |
|
| Cancer Stage (UICC 8th ed.) | Count of Participants | Participants |
|
|
|
| Primary | PD-L1 Prevalence ICC | Number/prevalence of PD-L1-positive patients according to immunocytochemistry (ICC) of pleural aspirate | Pleural puncture was performed in all fifty patients. PD-L1 analysis of pleural effusion was indicated in all samples with evidence of tumor cells (n=36), excluding cases with small-cell lung cancer (n=3). Mainly due to insufficient sample material (low tumor cell count) (n=7) or technical issue (n=1), PD-L1 analysis could actually be performed in 25 pleural effusion cases. | Posted | Count of Participants | Participants | At baseline |
|
|
|
| Primary | 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:
| Posted | Number | 95% Confidence Interval | percent | At baseline |
|
|
|
| Secondary | PD-L1 Detection in Pleural Effusion Based on All Cases With Indication for PD-L1 Analysis | 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:
| Posted | Number | 95% Confidence Interval | percent | At baseline |
|
|
|
| Secondary | Tumor Cell Detection in Pleural Effusion | 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. | Posted | Number | 95% Confidence Interval | percent | At baseline |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| PD-L1 negative |
|
| positive predictive value |
|
| negative predictive value |
|
| positive predictive value |
|
| negative predictive value |
|
| Title | Measurements |
|---|---|
|
| negative predictive value |
|