An observational study in Lung Neoplasms, sponsored by Wissenschaftliches Institut Bethanien e.V. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-05.
Sponsored by Wissenschaftliches Institut Bethanien e.V · Observational
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.
This study's enrollment of 50 is below the median of 189 across 1,512 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Wissenschaftliches Institut Bethanien e.V is the lead sponsor of 25 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
PD-L1 Prevalence IHC
Number/prevalence of PD-L1-positive patients according to immunohistochemistry (IHC) of pleural biopsy.
Time frame: At baseline
PD-L1 Prevalence ICC
Number/prevalence of PD-L1-positive patients according to immunocytochemistry (ICC) of pleural aspirate
Time frame: 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.
Time frame: At baseline
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: * 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.
Time frame: 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.
Time frame: At baseline
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.
| Milestone | Malignant Pleural Effusion |
|---|---|
| Started | 50 |
| Completed | 50 |
| Not completed | 0 |
Number/prevalence of PD-L1-positive patients according to immunohistochemistry (IHC) of pleural biopsy.
| Participants | Number of PD-L1-positive Samples in IHC |
|---|---|
| PD-L1 expression with a TPS ≥ 1% was defined as PD-L1-positive — PD-L1 positive | 21 |
| PD-L1 expression with a TPS ≥ 1% was defined as PD-L1-positive — PD-L1 negative | 14 |
| PD-L1 expression with a TPS ≥ 50% was defined as PD-L1-positive — PD-L1 positive | 8 |
| PD-L1 expression with a TPS ≥ 50% was defined as PD-L1-positive — PD-L1 negative | 27 |
Number/prevalence of PD-L1-positive patients according to immunocytochemistry (ICC) of pleural aspirate
| Participants | Number of PD-L1-positive Samples in ICC |
|---|---|
| PD-L1 expression with a TPS ≥ 1% was defined as PD-L1-positive — PD-L1 positive | 19 |
| PD-L1 expression with a TPS ≥ 1% was defined as PD-L1-positive — PD-L1 negative | 6 |
| PD-L1 expression with a TPS ≥ 50% was defined as PD-L1-positive — PD-L1 positive | 13 |
| PD-L1 expression with a TPS ≥ 50% was defined as PD-L1-positive — PD-L1 negative | 12 |
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.
| percent | Sensitivity and Specificity of PD-L1 Detection in Pleural Effusion (TPS ≥50%) | Sensitivity and Specificity of PD-L1 Detection in Pleural Effusion (TPS ≥1%) |
|---|---|---|
| Sensitivity | 100 (46 to 100) | 86 (56 to 97) |
| Specificity | 63 (36 to 84) | 43 (12 to 80) |
| positive predictive value | 45 (18 to 75) | 75 (47 to 92) |
| negative predictive value | 100 (66 to 100) | 60 (17 to 93) |
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.
| percent | Sensitivity and Specificity of PD-L1 Detection in Pleural Effusion (TPS ≥50%) | Sensitivity and Specificity of PD-L1 Detection in Pleural Effusion (TPS ≥1%) |
|---|---|---|
| Sensitivity | 71 (30 to 95) | 71 (44 to 89) |
| Specificity | 71 (49 to 87) | 64 (36 to 86) |
| positive predictive value | 42 (16 to 71) | 71 (44 to 89) |
| negative predictive value | 89 (65 to 98) | 64 (36 to 86) |
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.
| percent | Sensitivity and Specificity of Tumor Cell Detection |
|---|---|
| Sensitivity | 83 (67 to 89) |
| Specificity | 70 (35 to 92) |
| positive predictive value | 92 (76 to 98) |
| negative predictive value | 50 (24 to 76) |
Collected over 1 day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NSCLC With Pleural Effusion | 0/50 (0%) | 0/50 (0%) | 0/50 (0%) |
patients with confirmed diagnosis of non-small cell lung cancer
| Age, Continuous(years) | Malignant Pleural Effusion |
|---|---|
| Median | 72.5 (62.8 to 76.3) |
| Sex: Female, Male(Participants) | Malignant Pleural Effusion |
|---|---|
| Female | 17 |
| Male | 33 |
| Race (NIH/OMB)(Participants) | Malignant Pleural Effusion |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 50 |
| BMI(kg/m2) | Malignant Pleural Effusion |
|---|---|
| Median | 25.7 (23.2 to 28.5) |
| smoking status(Participants) | Malignant Pleural Effusion |
|---|---|
| never | 7 |
| ex-smoker | 28 |
| current smoker | 15 |
| Histology Type(Participants) | Malignant Pleural Effusion |
|---|---|
| NSCLC - Adeno carcinoma | 33 |
| NSCLC - Squamous cell carcinoma | 7 |
| NSCLC - large-cell neuroendocrine carcinoma | 1 |
| SCLC | 4 |
| SCLC + Adeno carcinoma | 1 |
| Non-Hodgkin Lymphoma | 1 |
| Sarcomatoid Mesothelioma | 1 |
| Ambiguous histology | 2 |
| Cancer Stage (UICC 8th ed.)(Participants) | Malignant Pleural Effusion |
|---|---|
| IA2 | 1 |
| IB | 1 |
| IIB | 3 |
| IIIA | 2 |
| IIIB | 2 |
| IVA | 24 |
| IVB | 15 |
| Unknown | 1 |
| III-IV (IMIG classification) | 1 |
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Wissenschaftliches Institut Bethanien e.V