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CompletedNCT03017183Updated Oct 30, 2018

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

An interventional study of EBUS-TBNA and Endobronchial forceps biopsy in Lung Neoplasms, sponsored by Wissenschaftliches Institut Bethanien e.V. Completed at 1 site in Germany. Open to participants aged 18 Years to 84 Years. Per ClinicalTrials.gov, last updated 2018-10-30.

Sponsored by Wissenschaftliches Institut Bethanien e.V · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 84 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Lung Neoplasms

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03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 30 is below the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Wissenschaftliches Institut Bethanien e.V is the lead sponsor of 25 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 84 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Other
    EBUS-TBNA - Endobrochial Forceps Biopsy

    In this arm, EBUS-TBNA will be done first, followed by endobronchial forceps biopsy

    Procedure: EBUS-TBNA · Procedure: Endobronchial forceps biopsy

  • Other
    Forceps - EBUS-TBNA

    In this arm, endobronchial forceps biopsy will be done first, followed by EBUS-TBNA

    Procedure: EBUS-TBNA · Procedure: Endobronchial forceps biopsy

Interventions

  • ProcedureEBUS-TBNA

    Endobronchial ultrasound guided transbronchial needle aspiration

  • ProcedureEndobronchial forceps biopsy

    Conventional endobronchial forceps biopsy

06

What researchers measure

Primary outcomes

  1. Number of detected mutations

    The number of different mutations detected based on each biopsy method as well as ctDNA analysis is determined

    Time frame: within 7 days after biopsy

07

Study locations

1 site
  • Krankenhaus Bethanien gGmbH
    Solingen, NRW 42699, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 30, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03017183
Lead sponsor
Wissenschaftliches Institut Bethanien e.V
Collaborators
AstraZeneca, Heinrich-Heine University, Duesseldorf
Responsible party
Sponsor
First posted
Jan 11, 2017
Start date
Jan 2, 2017
Primary completion
Jul 31, 2017
Completion
Jul 31, 2017
Last update
Oct 30, 2018

Study contacts

Winfried J Randerath, Prof. Dr.
principal investigator · Wissenschaftliches Institut Bethanien e.V

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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