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

Primary Purpose

Lung Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
EBUS-TBNA
Endobronchial forceps biopsy
Sponsored by
Wissenschaftliches Institut Bethanien e.V
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Neoplasms

Eligibility Criteria

18 Years - 84 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Krankenhaus Bethanien gGmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

EBUS-TBNA - Endobrochial Forceps Biopsy

Forceps - EBUS-TBNA

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 5, 2017
Last Updated
October 26, 2018
Sponsor
Wissenschaftliches Institut Bethanien e.V
Collaborators
AstraZeneca, Institute of Pathology, University Clinic Düsseldorf
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1. Study Identification

Unique Protocol Identification Number
NCT03017183
Brief Title
Detection of Heterogeneity in Central Lung Cancer - EBUS-TBNA and ctDNA Analysis vs. Endobronchial Forceps Biopsy
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 2, 2017 (Actual)
Primary Completion Date
July 31, 2017 (Actual)
Study Completion Date
July 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wissenschaftliches Institut Bethanien e.V
Collaborators
AstraZeneca, Institute of Pathology, University Clinic Düsseldorf

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasms

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EBUS-TBNA - Endobrochial Forceps Biopsy
Arm Type
Other
Arm Description
In this arm, EBUS-TBNA will be done first, followed by endobronchial forceps biopsy
Arm Title
Forceps - EBUS-TBNA
Arm Type
Other
Arm Description
In this arm, endobronchial forceps biopsy will be done first, followed by EBUS-TBNA
Intervention Type
Procedure
Intervention Name(s)
EBUS-TBNA
Intervention Description
Endobronchial ultrasound guided transbronchial needle aspiration
Intervention Type
Procedure
Intervention Name(s)
Endobronchial forceps biopsy
Intervention Description
Conventional endobronchial forceps biopsy
Primary Outcome Measure Information:
Title
Number of detected mutations
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Subjects eligible for enrolment in the study must meet all of the following criteria: Informed consent: a signed and dated written informed consent prior to study participation. Type of subject: inpatient Age: subjects of more than 18 years and less than 85 years. Central lesion in computed tomography highly suspicious of lung cancer with clinical indication for further diagnostic applying bronchoscopy. 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: Females who are pregnant or lactating , who decide not to undergo a bronchoscopy due to the risk for their child Any contraindication for bronchoscopy and EBUS-TBNA (IBNLT: INR>2, thrombocytopenia <40/nl) Drug/alcohol abuse impairing cognitive knowledge which is needed for a GCP conform informed consent. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Winfried J Randerath, Prof. Dr.
Organizational Affiliation
Wissenschaftliches Institut Bethanien e.V
Official's Role
Principal Investigator
Facility Information:
Facility Name
Krankenhaus Bethanien gGmbH
City
Solingen
State/Province
NRW
ZIP/Postal Code
42699
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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