Influence of Biopsy Technique on Moleculargenetic Tumor Characterisation in NSCLC

NCT ID: NCT03971175

Last Updated: 2022-07-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 540 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-19
• Study Completion Date: 2023-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: TRIPLE

Study Groups

Forceps group

Group Type: ACTIVE_COMPARATOR

Forceps biopsy

Intervention Type: PROCEDURE

Endobronchial biopsy with the forceps

Cryobiopsy group

Group Type: EXPERIMENTAL

Cryobiopsy

Intervention Type: PROCEDURE

Endobronchial biopsy with the cryobiopsy probe

Interventions

Forceps biopsy

Endobronchial biopsy with the forceps

Intervention Type: PROCEDURE

Cryobiopsy

Endobronchial biopsy with the cryobiopsy probe

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Provision of informed consent to the study and the study specific procedures prior to any study intervention

2. Male or female patients aged ≥18 years

3. Patients with primary diagnosis of suspected lung cancer OR Patients with known NSCLC and suspected relapse after therapy

4. Bronchoscopically visible tumor

Exclusion Criteria

1. Preexisting malignancy other than NSCLC

2. Contraindication for bronchoscopy according to the international guidelines, daily clinical practice and the local regulations with

• Patients with existing or at risk of pulmonary and cardiovascular decompensation
• Patients at increased risk of bleeding with antiplatelet agents except of aspirin (clopidogrel, ticlopidine, …) , anticoagulant therapy (prolonged PTT), thrombocytopenia (< 50.000/ul) or coagulopathy (prolonged in vitro bleeding time).
• Intolerance to sedation
• Unstable or immobile cervical spine
• Limited motion of the temporomandibular joint

3. Previous enrolment in the present study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Tuebingen

Tübingen, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Maik Haentschel, MD

Role: CONTACT

maik.haentschel@med.uni-tuebingen.de

+49707129 ext. 82711

Juergen Hetzel, MD

Role: CONTACT

juergen.hetzel@med.uni-tuebingen.de

+49707129 ext. 82711

Facility Contacts

Maik Haentschel, MD

Role: primary

maik.Haentschel@med.uni-tuebingen.de

+49707129 ext. 82711

Juergen Hetzel, MD

Role: backup

juergen.hetzel@med.uni-tuebingen.de

+49707129 ext. 82711

Other Identifiers

PROFILER study

Identifier Type: -

Identifier Source: org_study_id