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The primary purpose of this non-interventional, multinational study is to assess the feasibility of assessing PD-L1 protein expression on cytological samples as a surrogate for histological samples obtained from participants with any stage of non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cytological and Histological Samples | Cytological and histological specimens that meet the eligibility criteria will be analyzed only from those participants who have consented to biomarker research, according to local regulations and ethical guidelines. Cytological samples may originate from fine needle aspirations. Pleural effusions or bronchial cytology samples (brushings and washings) may be allowed. Histological samples may originate from core needle biopsies, bronchial biopsies (thoracoscopy or mediastinoscopy) or surgical tissue resections. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-L1 Immunocytochemistry (ICC) | Diagnostic Test | PD-L1 expression in the cytological specimens will be assessed using different antibodies. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Total Tumor Cells (TC) That Display Discernible PD-L1 Staining of any Intensity in Histological and Cytological Samples As Assessed Using PD-L1 IHC/ICC Assay | approximately 12 months | |
| Percentage of Total TC Within ten High-Power Fields (HPF) That Display Discernible PD-L1 Staining of any Intensity in Histological and Cytological Samples As Assessed Using PD-L1 IHC/ICC Assay | approximately 12 months | |
| Percentage of Total Tumor Area That Contain Tumor-Infiltrating Immune Cells of any Discernible PD-L1 Staining of any Intensity in Histological Samples As Assessed Using PD-L1 IHC Assay | approximately 12 months | |
| Percentage of Total Immune Cells That Display Discernible PD-L1 Staining of any Intensity in Cytological Samples As Assessed Using PD-L1 ICC Assay | approximately 12 months | |
| Percentage of Total Immune Cells Within ten HPF That Display Discernible PD-L1 Staining of any Intensity in Histological and Cytological Samples As Assessed Using PD-L1 IHC/ICC Assay | approximately 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with any stage of NSCLC or SCLC who have cytological and histological samples available.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vseobecna fakultni nemocnice v Praze; I. klinika tuberkulozy a respiracnich nemoci | Prague | 128 08 | Czechia | |||
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Formalin fixed, paraffin embedded tumor tissue; formalin fixed paraffin embedded cytological samples (cell blocks) from the same participant will be retained until end of the study.
| PD-L1 Immunohistochemistry (IHC) | Diagnostic Test | PD-L1 expression in the histological specimens will be assessed using different antibodies. |
|
| Universitätsklinikum Göttingen, Institut für Pathologie |
| Göttingen |
| 37075 |
| Germany |
| Instytut Gruźlicy i Chorób Płuc, I Klinika Chorób Płuc | Warsaw | 01-138 | Poland |
| Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Anatomía Patológica | A Coruña | LA Coruña | 15006 | Spain |
| Hospital Universitario La Paz; Servicio de Anatomia Patologica | Madrid | 28046 | Spain |
| HOSPITAL DE MADRID NORTE SANCHINARRO- C. INTEGRAL ONC. CLARA CAMPAL; Servicio Anatomia Patologica | Madrid | 28050 | Spain |
| Universitätsspital Basel; Pathologie | Basel | 4031 | Switzerland |
| Aberdeen Royal Infirmary | Aberdeen | AB25 2ZN | United Kingdom |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D018288 | Carcinoma, Small Cell |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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