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JOURNAL ONKOLOGIE – STUDIE
PROFILER

Influence of Biopsy Technique on Moleculargenetic Tumor Characterisation in NSCLC

Rekrutierend

NCT-Nummer:
NCT03971175

Studienbeginn:
Dezember 2018

Letztes Update:
03.06.2019

Wirkstoff:
-

Indikation (Clinical Trials):
Carcinoma, Non-Small-Cell Lung

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
University Hospital Tuebingen, University Hospital Tuebingen

Collaborator:
AstraZeneca, AstraZeneca

Kontakt

Maik Haentschel, MD
Kontakt:
Phone: +49707129
Phone (ext.): 82711
E-Mail: maik.haentschel@med.uni-tuebingen.de
» Kontaktdaten anzeigen
Juergen Hetzel, MD
Kontakt:
Phone: +49707129
Phone (ext.): 82711
E-Mail: juergen.hetzel@med.uni-tuebingen.de
» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

University of Tuebingen
72076 Tuebingen
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Maik Haentschel, MD
Phone: +49707129
Phone (ext.): 82711
E-Mail: maik.Haentschel@med.uni-tuebingen.de

Juergen Hetzel, MD
Phone: +49707129
Phone (ext.): 82711
E-Mail: juergen.hetzel@med.uni-tuebingen.de
» Ansprechpartner anzeigen

Studien-Informationen

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.
 

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Detection of at least one molecular and/ or genetic alteration. (Time Frame - recruiting period approximately 24 months):
assessment of differences in detection of molecular genetic alterations in NSCLC between bronchoscopic forceps biopsy and bronchoscopic cryobiopsy

2. Differences in the detection of total mutational burden between both techniques. (Time Frame - 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:

1. Detection of any molecular and/ or genetic alterations (Time Frame - 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

2. Combinations of molecular and/ or genetic alterations (Time Frame - 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

3. Differences in the quantity of total mutational burden between the different techniques (Time Frame - 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

Studien-Arme

  • Active Comparator: Forceps group
  • Experimental: Cryobiopsy group

Geprüfte Regime

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

Quelle: ClinicalTrials.gov


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