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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03017183

Enrollment

Registered

2017-01-11

Start date

2017-01-02

Completion date

2017-07-31

Last updated

2018-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Neoplasms

Brief 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.

Interventions

PROCEDUREEBUS-TBNA

Endobronchial ultrasound guided transbronchial needle aspiration

PROCEDUREEndobronchial forceps biopsy

Conventional endobronchial forceps biopsy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 84 Years

Healthy volunteers

Inclusion criteria

Subjects eligible for enrolment in the study must meet all of the following criteria: 1. Informed consent: a signed and dated written informed consent prior to study participation. 2. Type of subject: inpatient 3. Age: subjects of more than 18 years and less than 85 years. 4. Central lesion in computed tomography highly suspicious of lung cancer with clinical indication for further diagnostic applying bronchoscopy. 5. 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: 1. Females who are pregnant or lactating , who decide not to undergo a bronchoscopy due to the risk for their child 2. Any contraindication for bronchoscopy and EBUS-TBNA (IBNLT: INR\>2, thrombocytopenia \<40/nl) 3. Drug/alcohol abuse impairing cognitive knowledge which is needed for a GCP conform informed consent. 4. 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.

Design outcomes

Primary

Measure	Time frame	Description
Number of detected mutations	within 7 days after biopsy	The number of different mutations detected based on each biopsy method as well as ctDNA analysis is determined

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026