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

October 26, 2018 updated by: Wissenschaftliches Institut Bethanien e.V

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Solingen, NRW, Germany, 42699
        • Krankenhaus Bethanien gGmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 84 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wissenschaftliches Institut Bethanien e.V

Collaborators

AstraZeneca
Institute of Pathology, University Clinic Düsseldorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 2, 2017

Primary Completion (ACTUAL)

July 31, 2017

Study Completion (ACTUAL)

July 31, 2017

Study Registration Dates

First Submitted

January 5, 2017

First Submitted That Met QC Criteria

January 10, 2017

First Posted (ESTIMATE)

January 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 30, 2018

Last Update Submitted That Met QC Criteria

October 26, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WI_EBUS-TBNA_16-226

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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