NCT05602259

PROspective Trial on EOsinophilia in Non-Small Cell Lung Cancer (NSCLC).

PROspective Trial on EOsinophilia in Non-Small Cell Lung Cancer (NSCLC) (PROTEON).

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Liege · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-10-27
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2022-11-02
• Last updated: 2024-02-09

Locations

1 site across 1 country: Belgium