Influence of Biopsy Technique on Moleculargenetic Tumor Characterisation in NSCLC (PROFILER)

University Hospital Tuebingen

Status: Unknown

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

Treatments: Procedure: Cryobiopsy; Procedure: Forceps biopsy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03971175

PROFILER study

Details and patient eligibility

About

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.

Enrollment: 540 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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540 participants in 2 patient groups

Forceps group

Active Comparator group

Treatment:

Procedure: Forceps biopsy

Cryobiopsy group

Experimental group

Treatment:

Procedure: Cryobiopsy