PROspective Trial on EOsinophilia in Non-Small Cell Lung Cancer (NSCLC).
NCT ID: NCT05602259
Last Updated: 2024-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2022-10-27
2025-05-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Eosinophil detection
Eosinophils will be measured in blood, sputum, bronchoalveolar lavage if available and biopsies.
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.
lung biopsy
As per standard practice, biopsies will be taken from the primary tumour site or from a metastatic site.
bronchoalveolar lavage
When available, the remaining material from a patient's bronchoalveolar lavage will be collected.
blood draw
As per standard practice, blood will be drawn from patients before and during treatment. Data on white blood cells will be collected.
Interventions
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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.
lung biopsy
As per standard practice, biopsies will be taken from the primary tumour site or from a metastatic site.
bronchoalveolar lavage
When available, the remaining material from a patient's bronchoalveolar lavage will be collected.
blood draw
As per standard practice, blood will be drawn from patients before and during treatment. Data on white blood cells will be collected.
Eligibility Criteria
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Inclusion Criteria
* Stage III-IV NSCLC eligible for ICI treatment
* 18 years or older; non pregnant women
* in stage III-IV: no previous ICI and before ICI (mono- or combination therapy) initiation
* Signed informed consent
* Clinical, biological and radiological evaluation at the CHU de Liège for at least 6 months following treatment initiation
Exclusion Criteria
* Inclusion in a clinical study contraindicating the enrolment in the PROTEON study
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Liege
OTHER
Responsible Party
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Anne Sibille
Dr Anne Sibille
Locations
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CHU de Liège
Liège, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022/258
Identifier Type: -
Identifier Source: org_study_id
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