PROFILER: Influence of Biopsy Technique on Moleculargenetic Tumor Characterisation in NSCLC

Sponsor

University Hospital Tuebingen (Other)

Overall Status

Recruiting

CT.gov ID

NCT03971175

Collaborator

AstraZeneca (Industry)

540

Enrollment

Location

Arms

54.3

Anticipated Duration (Months)

9.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Non-Small-Cell Lung Pathology, Molecular	Procedure: Forceps biopsy Procedure: Cryobiopsy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

540 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Diagnostic

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

Actual Study Start Date :

Dec 19, 2018

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Jun 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Forceps group	Procedure: Forceps biopsy Endobronchial biopsy with the forceps
Experimental: Cryobiopsy group	Procedure: Cryobiopsy Endobronchial biopsy with the cryobiopsy probe

Arm

Intervention/Treatment

Active Comparator: Forceps group

Procedure: Forceps biopsy

Endobronchial biopsy with the forceps

Experimental: Cryobiopsy group

Procedure: Cryobiopsy

Endobronchial biopsy with the cryobiopsy probe

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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
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
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

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Tuebingen	Tuebingen		Germany	72076

Sponsors and Collaborators

University Hospital Tuebingen
AstraZeneca

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital Tuebingen

ClinicalTrials.gov Identifier:

NCT03971175

Other Study ID Numbers:

PROFILER study

First Posted:

Jun 3, 2019

Last Update Posted:

Jul 26, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Jul 26, 2022