PROspective Trial on EOsinophilia in Non-Small Cell Lung Cancer (NSCLC).
NCT05602259 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2024-02-09
Summary
This prospective study will examine eosinophils in various biological materials to compare the detection in those materials and ascertain the prognostic and predictive role of eosinophils in untreated non-small cell lung cancer patient.
Conditions
Interventions
- DIAGNOSTIC_TEST
-
induced sputum
After premedication with 400 μg inhaled salbutamol, sputum will be induced by inhalation of hypertonic (NaCl 3%) or isotonic (NaCl 0.9%) saline combined according to the FEV-1 value (\> or ≤ than 65% predicted). Saline will be combined with additional salbutamol delivered by an ultrasonic nebulizer (Ultra-Neb 2000; Devilbiss, Somerset, PA, USA) with an output set at 0.9 ml/min. Each subject will inhale the aerosol for three consecutive periods of 5 min for a total of 15 min. For safety reasons, FEV-1 will be monitored throughout the induction and will be stopped if FEV-1 would fall by more than 20% from baseline.
- DIAGNOSTIC_TEST
-
lung biopsy
As per standard practice, biopsies will be taken from the primary tumour site or from a metastatic site.
- DIAGNOSTIC_TEST
-
bronchoalveolar lavage
When available, the remaining material from a patient's bronchoalveolar lavage will be collected.
- DIAGNOSTIC_TEST
-
blood draw
As per standard practice, blood will be drawn from patients before and during treatment. Data on white blood cells will be collected.
Sponsors & Collaborators
-
Centre Hospitalier Universitaire de Liege
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-10-27
- Primary Completion
- 2025-05-01
- Completion
- 2025-05-01
Countries
- Belgium
Study Locations
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