Influence of Biopsy Technique on Moleculargenetic Tumor Characterisation in NSCLC

NCT03971175 | Unknown DMC

• 1 other identifier: PROFILER study
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Detection of any molecular and/ or genetic alterations

  recruiting period approximately 24 months

• Combinations of 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

Other Outcomes (2)

• Qualitative tumor DNA determination using next generation sequencing techniques for the different specimens

  recruiting period approximately 24 months

• Quantitative tumor DNA determination using next generation sequencing techniques for the different specimens

  recruiting period approximately 24 months

Study Arms (2)

Forceps group

ACTIVE COMPARATOR

Procedure: Forceps biopsy

Cryobiopsy group

EXPERIMENTAL

Procedure: Cryobiopsy

Interventions

Forceps biopsy PROCEDURE

Endobronchial biopsy with the forceps

Forceps group

Cryobiopsy PROCEDURE

Endobronchial biopsy with the cryobiopsy probe

Cryobiopsy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• AstraZeneca: collaborator

Study Sites (1)

University of Tuebingen

Tübingen, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Maik Haentschel, MD

CONTACT

+49707129; maik.haentschel@med.uni-tuebingen.de

Juergen Hetzel, MD

CONTACT

+49707129; juergen.hetzel@med.uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2019
• First Posted: June 3, 2019
• Study Start: December 19, 2018
• Primary Completion: September 30, 2022
• Study Completion: June 30, 2023
• Last Updated: July 26, 2022

Record last verified: 2022-04

Locations

DE (1)