Non-small Cell Lung Cancer
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTinduced 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_TESTlung biopsy
As per standard practice, biopsies will be taken from the primary tumour site or from a metastatic site.
DIAGNOSTIC_TESTbronchoalveolar lavage
When available, the remaining material from a patient's bronchoalveolar lavage will be collected.
DIAGNOSTIC_TESTblood draw
As per standard practice, blood will be drawn from patients before and during treatment. Data on white blood cells will be collected.
Sponsors
Centre Hospitalier Universitaire de Liege
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* o All stages of NSCLC * 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
* Probable noncompliance with the follow-up requirements of the study (psychiatric condition, socio-economic factors) * Inclusion in a clinical study contraindicating the enrolment in the PROTEON study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of eosinophils in untreated non-small cell lung cancer patients | Baseline (pre-treatment) | Concentration of eosinophils will be used in various bodily materials as described above. |
Secondary
| Measure | Time frame |
|---|---|
| Prognostic and predictive value of eosinophils in non-small cell lung cancer patients | Baseline (pre-treatment) and, if immunotherapy, after 3 months of treatment |
Countries
Belgium
Contacts
Primary ContactAnne Sibille, MD
Backup ContactAurore Cue Alvarez
Outcome results
None listed