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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05602259 on ClinicalTrials.gov