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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
| Heinrich-Heine University, Duesseldorf | OTHER |
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Study participants will be selected from clinical routine patients with endobronchial infiltration of a central lung cancer and indication for bronchoscopic sampling.
Consented patients will undergo bronchoscopy for tumor sampling applying two routine sampling methods during one single procedure (EBUS-TBNA and conventional forceps sampling). The sequence of both sampling methods will be randomized in advance.
The resulting tissue samples will be analyzed by a pathologist using multiplex PCR and FISH. The corresponding analysis results will be compared between sampling methods.
Assignment of a subject to a particular therapeutic strategy is not influenced by this protocol. Medicinal products will be used according to current practice and marketing authorisation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EBUS-TBNA - Endobrochial Forceps Biopsy | Other | In this arm, EBUS-TBNA will be done first, followed by endobronchial forceps biopsy |
|
| Forceps - EBUS-TBNA | Other | In this arm, endobronchial forceps biopsy will be done first, followed by EBUS-TBNA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EBUS-TBNA | Procedure | Endobronchial ultrasound guided transbronchial needle aspiration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of detected mutations | The number of different mutations detected based on each biopsy method as well as ctDNA analysis is determined | within 7 days after biopsy |
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Inclusion criteria:
Subjects eligible for enrolment in the study must meet all of the following criteria:
Exclusion criteria:
Subjects meeting any of the following criteria must not be enrolled in 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 |
|---|---|---|---|---|---|---|
| Krankenhaus Bethanien gGmbH | Solingen | North Rhine-Westphalia | 42699 | Germany |
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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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| Endobronchial forceps biopsy | Procedure | Conventional endobronchial forceps biopsy |
|
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |