Influence of Biopsy Technique on Moleculargenetic Tumor Characterisation in NSCLC

Not Applicable

• Conditions: Carcinoma, Non-Small-Cell Lung; Pathology, Molecular
• Interventions: Procedure: Cryobiopsy; Procedure: Forceps biopsy

• Registration Number: NCT03971175
• Lead Sponsor: University Hospital Tuebingen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-19
• Study First Submitted: 2019-03-11
• Study First Submitted QC: 2019-05-29
• Study First Posted: 2019-06-03
• Status Verified: 2022-04
• Last Update Submitted: 2022-07-25
• Last Update Posted: 2022-07-26
• Primary Completion: 2022-09-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 540

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cryobiopsy group	Cryobiopsy	-
Forceps group	Forceps biopsy	-

Primary Outcome Measures

Name	Time	Method
Differences in the detection of total mutational burden between both techniques.	recruiting period approximately 24 months	assessment of differences in detection of molecular genetic alterations in NSCLC between bronchoscopic forceps biopsy and bronchoscopic cryobiopsy
Detection of at least one molecular and/ or genetic alteration.	recruiting period approximately 24 months	assessment of differences in detection of molecular genetic alterations in NSCLC between bronchoscopic forceps biopsy and bronchoscopic cryobiopsy

Secondary Outcome Measures

Name	Time	Method
Combinations of molecular and/ or genetic alterations	recruiting period approximately 24 months	assessment of differences in detection rate of molecular genetic alterations in NSCLC between; * different bronchoscopic (forceps/ cryobiopsy) specimens (No 1 to No 4); * 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
Detection of any molecular and/ or genetic alterations	recruiting period approximately 24 months	assessment of differences in detection rate of molecular genetic alterations in NSCLC between; * different bronchoscopic (forceps/ cryobiopsy) specimens (No 1 to No 4); * 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
Differences in the quantity of total mutational burden between the different techniques	recruiting period approximately 24 months	assessment of differences in the quantity of total mutational burden between; * different bronchoscopic (forceps/ cryobiopsy) specimens (No 1 to No 4); * 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

Trial Locations

Locations (1)

University of Tuebingen; 🇩🇪 Tuebingen, Germany