Detection of Heterogeneity in Central Lung Cancer - EBUS-TBNA and ctDNA Analysis vs. Endobronchial Forceps Biopsy

Study Overview
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Brief Summary
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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.

Official Title
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Detection of Heterogeneity in Central Lung Cancer - Prospective Randomized Controlled Trial to Evaluate the Diagnostic Value of EBUS-TBNA and ctDNA Analysis Compared to Endobronchial Forceps Biopsy

Conditions
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Lung Neoplasms

Intervention / Treatment
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* Procedure: EBUS-TBNA
* Procedure: Endobronchial forceps biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Subjects eligible for enrolment in the study must meet all of the following criteria: Informed consent: a signed and dated written informed consent prior to study participation. Type of subject: inpatient Age: subjects of more than 18 years and less than 85 years. Central lesion in computed tomography highly suspicious of lung cancer with clinical indication for further diagnostic applying bronchoscopy. Central lesion has to be accessible by the biopsy techniques under investigation Exclusion criteria: Subjects meeting any of the following criteria must not be enrolled in the study: Females who are pregnant or lactating , who decide not to undergo a bronchoscopy due to the risk for their child Any contraindication for bronchoscopy and EBUS-TBNA (IBNLT: INR>2, thrombocytopenia <40/nl) Drug/alcohol abuse impairing cognitive knowledge which is needed for a GCP conform informed consent. Inability to read or inability of language: in the opinion of the investigator, any subject who is unable to read and/or would not be able to complete study related materials.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: EBUS-TBNA - Endobrochial Forceps Biopsy<br>In this arm, EBUS-TBNA will be done first, followed by endobronchial forceps biopsy | Procedure: EBUS-TBNA<br>* Endobronchial ultrasound guided transbronchial needle aspiration<br>Procedure: Endobronchial forceps biopsy<br>* Conventional endobronchial forceps biopsy<br>|
| Other: Forceps - EBUS-TBNA<br>In this arm, endobronchial forceps biopsy will be done first, followed by EBUS-TBNA | Procedure: EBUS-TBNA<br>* Endobronchial ultrasound guided transbronchial needle aspiration<br>Procedure: Endobronchial forceps biopsy<br>* Conventional endobronchial forceps biopsy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |