Carcinoma, Non-Small-Cell Lung, Pathology, Molecular
Conditions
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.
Interventions
PROCEDUREForceps biopsy
Endobronchial biopsy with the forceps
PROCEDURECryobiopsy
Endobronchial biopsy with the cryobiopsy probe
Sponsors
AstraZeneca
University Hospital Tuebingen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Qualitative tumor DNA determination using next generation sequencing techniques for the different specimens | recruiting period approximately 24 months | 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 |
| Quantitative tumor DNA determination using next generation sequencing techniques for the different specimens | recruiting period approximately 24 months | 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 |
Countries
Germany
Contacts
Primary ContactMaik Haentschel, MD
Backup ContactJuergen Hetzel, MD
Outcome results
None listed