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Influence of Biopsy Technique on Moleculargenetic Tumor Characterisation in NSCLC

NCT03971175 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 540

Last updated 2022-07-26

No results posted yet for this study

Summary

Study design Prospective multicentre explorative randomized single blinded study to evaluate accuracy of molecular genetic characterisation of NSCLC. Patients with suspected lung cancer are randomized in a 1:1-setting for bronchoscopic tumor tissue either by forceps or by cryobiopsy. Apart from the bronchoscopic techniques liquid biopsy of peripheral blood and if feasible transbronchial needle aspiration with or without endobronchial ultrasound guidance are performed for in all patients.

Objectives

Primary Objective:

assessment of differences in detection of molecular genetic alterations in NSCLC between bronchoscopic forceps biopsy and bronchoscopic cryobiopsy

Secondary Objective:

assessment of differences in detection of molecular genetic alterations in NSCLC between

* liquid biopsy, solid tumor tissue by bronchoscopic techniques, cytologic material by TBNA
* combination of methods (tissue biopsy, TBNA and liquid biopsy) and single techniques
* naïve and processed tumor tissue specimen (eg. microdissection)

To assess differences in side effects e.g. periinterventional bleeding

Explorative Objective:

To explore tumor mutational burden with regard to

* solid tumor tissue by bronchoscopic forceps biopsy by bronchoscopic cryobiopsy
* cytologic material by (EBUS-guided) TBNA
* liquid biopsy

Target subject population Patients with suspected lung cancer or proven NSCLC and visible tumor suspicious lesion(s) requiring tissue diagnosis form the study population of this trial.

Conditions

  • Carcinoma, Non-Small-Cell Lung
  • Pathology, Molecular

Interventions

PROCEDURE

Forceps biopsy

Endobronchial biopsy with the forceps

PROCEDURE

Cryobiopsy

Endobronchial biopsy with the cryobiopsy probe

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • University Hospital Tuebingen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-19
Primary Completion
2022-09-30
Completion
2023-06-30

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 NCT03971175 on ClinicalTrials.gov