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

NCT05602259 — Not applicable, Unknown, 200 participants, Centre Hospitalier Universitaire de Liege

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

Registry	NCT05602259, acronym PROTEON
Status	Unknown
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, diagnostic
Enrollment	200 (Estimated)
Sponsor	Centre Hospitalier Universitaire de Liege (Other)
Conditions	Non-small Cell Lung Cancer
Interventions	induced sputum, lung biopsy, bronchoalveolar lavage, blood draw (Diagnostic test)
Dates	start 2022-10-27, primary completion 2025-05-01 (estimated), completion 2025-05-01 (estimated), first posted 2022-11-02, last updated 2024-02-09
Locations	1 site in Belgium

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Eosinophil detection	Experimental	Diagnostic Test: induced sputum; Diagnostic Test: lung biopsy; Diagnostic Test: bronchoalveolar lavage; Diagnostic Test: blood draw	Eosinophils will be measured in blood, sputum, bronchoalveolar lavage if available and biopsies.

induced sputum (Diagnostic test): 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 (Diagnostic test): As per standard practice, biopsies will be taken from the primary tumour site or from a metastatic site.
bronchoalveolar lavage (Diagnostic test): When available, the remaining material from a patient's bronchoalveolar lavage will be collected.
blood draw (Diagnostic test): As per standard practice, blood will be drawn from patients before and during treatment. Data on white blood cells will be collected.

+Outcome measures

Primary outcomes

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 outcomes

Prognostic and predictive value of eosinophils in non-small cell lung cancer patients [Baseline (pre-treatment) and, if immunotherapy, after 3 months of treatment]

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

Facility	City	Country	Status
CHU de Liège	Liège	Belgium	Recruiting