Trials / Completed
CompletedNCT03017183
Detection of Heterogeneity in Central Lung Cancer - EBUS-TBNA and ctDNA Analysis vs. Endobronchial Forceps Biopsy
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Wissenschaftliches Institut Bethanien e.V · Academic / Other
- Sex
- All
- Age
- 18 Years – 84 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | EBUS-TBNA | Endobronchial ultrasound guided transbronchial needle aspiration |
| PROCEDURE | Endobronchial forceps biopsy | Conventional endobronchial forceps biopsy |
Timeline
- Start date
- 2017-01-02
- Primary completion
- 2017-07-31
- Completion
- 2017-07-31
- First posted
- 2017-01-11
- Last updated
- 2018-10-30
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT03017183. Inclusion in this directory is not an endorsement.