Clinical trial NCT03971175: Influence of Biopsy Technique on Moleculargenetic Tumor Characterisation in NSCLC
Official title: A Prospective, Randomized, Single Blinded Multicentre Trial to Evaluate Molecular Genetic Characterisation of Primary Diagnosed or Relapsed Non Small Cell Lung Cancer by Single or Combination of Diagnostic Procedures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Carcinoma, Non-Small-Cell Lung
Pathology, Molecular
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2019-06-03
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Detection of at least one molecular and/ or genetic alteration.
timeFrame: recruiting period approximately 24 months
measure: Differences in the detection of total mutational burden between both techniques.
timeFrame: recruiting period approximately 24 months
Secondary outcomes:
measure: Detection of any molecular and/ or genetic alterations
timeFrame: recruiting period approximately 24 months
measure: Combinations of molecular and/ or genetic alterations
timeFrame: recruiting period approximately 24 months
measure: Differences in the quantity of total mutational burden between the different techniques
timeFrame: recruiting period approximately 24 months
Other outcomes:
measure: Qualitative tumor DNA determination using next generation sequencing techniques for the different specimens
timeFrame: recruiting period approximately 24 months
measure: Quantitative tumor DNA determination using next generation sequencing techniques for the different specimens
timeFrame: recruiting period approximately 24 months
Locations:
city: Tuebingen
country: Germany
facility: University of Tuebingen
Study officials:
References: