Influence of Biopsy Technique on Moleculargenetic Tumor Characterisation in NSCLC

Carcinoma, Non-Small-Cell Lung Clinical Trial

— PROFILER  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03971175
• Other study ID #: PROFILER study
• Status: Recruiting
• Phase: N/A
• Start date: December 19, 2018
• Est. completion date: June 30, 2023

Study information

• Verified date: April 2022
• Source: University Hospital Tuebingen
• Contact: Maik Haentschel, MD
• Phone: +49707129
• Email: maik.haentschel[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 540
• Est. completion date: June 30, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Pathology, Molecular

Intervention

Procedure:
• Forceps biopsy
Endobronchial biopsy with the forceps
• Cryobiopsy
Endobronchial biopsy with the cryobiopsy probe

Locations

Country	Name	City	State
Germany	University of Tuebingen	Tuebingen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Tuebingen	AstraZeneca

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Qualitative tumor DNA determination using next generation sequencing techniques for the different specimens	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	recruiting period approximately 24 months
Other	Quantitative tumor DNA determination using next generation sequencing techniques for the different specimens	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	recruiting period approximately 24 months
Primary	Detection of at least one molecular and/ or genetic alteration.	assessment of differences in detection of molecular genetic alterations in NSCLC between bronchoscopic forceps biopsy and bronchoscopic cryobiopsy	recruiting period approximately 24 months
Primary	Differences in the detection of total mutational burden between both techniques.	assessment of differences in detection of molecular genetic alterations in NSCLC between bronchoscopic forceps biopsy and bronchoscopic cryobiopsy	recruiting period approximately 24 months
Secondary	Detection of any molecular and/ or genetic alterations	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	recruiting period approximately 24 months
Secondary	Combinations of molecular and/ or genetic alterations	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	recruiting period approximately 24 months
Secondary	Differences in the quantity of total mutational burden between the different techniques	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	recruiting period approximately 24 months