NCT03017183

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 11, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
Last Updated

October 30, 2018

Status Verified

October 1, 2018

Enrollment Period

7 months

First QC Date

January 5, 2017

Last Update Submit

October 26, 2018

Conditions

Lung Neoplasms

Outcome Measures

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

    within 7 days after biopsy

Study Arms (2)

EBUS-TBNA - Endobrochial Forceps Biopsy

OTHER

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

Procedure: EBUS-TBNAProcedure: Endobronchial forceps biopsy

Forceps - EBUS-TBNA

OTHER

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

Procedure: EBUS-TBNAProcedure: Endobronchial forceps biopsy

Interventions

EBUS-TBNAPROCEDURE

Endobronchial ultrasound guided transbronchial needle aspiration

EBUS-TBNA - Endobrochial Forceps BiopsyForceps - EBUS-TBNA
Endobronchial forceps biopsyPROCEDURE

Conventional endobronchial forceps biopsy

EBUS-TBNA - Endobrochial Forceps BiopsyForceps - EBUS-TBNA

Eligibility Criteria

Age18 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Krankenhaus Bethanien gGmbH

Solingen, North Rhine-Westphalia, 42699, Germany

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Winfried J Randerath, Prof. Dr.

    Wissenschaftliches Institut Bethanien e.V

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2017

First Posted

January 11, 2017

Study Start

January 2, 2017

Primary Completion

July 31, 2017

Study Completion

July 31, 2017

Last Updated

October 30, 2018

Record last verified: 2018-10

Locations

DE(1)