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NCT Number: NCT03017183

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

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Key information

Conditions

Lung Neoplasms Lung Diseases Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Krankenhaus Bethanien gGmbH

Solingen, North Rhine-Westphalia, 42699, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EBUS-TBNA

Procedure

Endobronchial ultrasound guided transbronchial needle aspiration

Endobronchial forceps biopsy

Procedure

Conventional endobronchial forceps biopsy

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Wissenschaftliches Institut Bethanien e.V

Other

Collaborators

  • AstraZeneca
  • Heinrich-Heine University, Duesseldorf

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 11, 2017
Registry last updated
Oct 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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