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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03017183
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : October 30, 2018
Sponsor:
Collaborators:
AstraZeneca
Institute of Pathology, University Clinic Düsseldorf
Information provided by (Responsible Party):
Wissenschaftliches Institut Bethanien e.V

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.


Condition or disease Intervention/treatment Phase
Lung Neoplasms Procedure: EBUS-TBNA Procedure: Endobronchial forceps biopsy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Actual Study Start Date : January 2, 2017
Actual Primary Completion Date : July 31, 2017
Actual Study Completion Date : July 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017183


Locations
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Germany
Krankenhaus Bethanien gGmbH
Solingen, NRW, Germany, 42699
Sponsors and Collaborators
Wissenschaftliches Institut Bethanien e.V
AstraZeneca
Institute of Pathology, University Clinic Düsseldorf
Investigators
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Principal Investigator: Winfried J Randerath, Prof. Dr. Wissenschaftliches Institut Bethanien e.V
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Responsible Party: Wissenschaftliches Institut Bethanien e.V
ClinicalTrials.gov Identifier: NCT03017183    
Other Study ID Numbers: WI_EBUS-TBNA_16-226
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases