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
试验速览
- 阶段
- 不适用
- 入组人数
- 540
- 试验地点
- 2
- 主要终点
- Differences in the detection of total mutational burden between both techniques.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent to the study and the study specific procedures prior to any study intervention
- •Male or female patients aged ≥18 years
- •Patients with primary diagnosis of suspected lung cancer OR Patients with known NSCLC and suspected relapse after therapy
- •Bronchoscopically visible tumor
排除标准
- •Preexisting malignancy other than NSCLC
- •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
- •Previous enrolment in the present study
结局指标
主要结局
Differences in the detection of total mutational burden between both techniques.
时间窗: 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.
时间窗: recruiting period approximately 24 months
assessment of differences in detection of molecular genetic alterations in NSCLC between bronchoscopic forceps biopsy and bronchoscopic cryobiopsy
次要结局
- Combinations of molecular and/ or genetic alterations(recruiting period approximately 24 months)
- Detection of any molecular and/ or genetic alterations(recruiting period approximately 24 months)
- Differences in the quantity of total mutational burden between the different techniques(recruiting period approximately 24 months)