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

NCT03017183 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-10-30

No results posted yet for this study

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.

Conditions

  • Lung Neoplasms

Interventions

PROCEDURE

EBUS-TBNA

Endobronchial ultrasound guided transbronchial needle aspiration

PROCEDURE

Endobronchial forceps biopsy

Conventional endobronchial forceps biopsy

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Heinrich-Heine University, Duesseldorf

    collaborator OTHER

  • Wissenschaftliches Institut Bethanien e.V

    lead OTHER

Principal Investigators

  • Winfried J Randerath, Prof. Dr. · Wissenschaftliches Institut Bethanien e.V

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-02
Primary Completion
2017-07-31
Completion
2017-07-31

Countries

  • Germany

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03017183 on ClinicalTrials.gov