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

Sponsor

Centre Hospitalier Universitaire de Liege (Other)

Overall Status

Recruiting

CT.gov ID

NCT05602259

Collaborator

(none)

200

Enrollment

Location

Arm

30.1

Anticipated Duration (Months)

6.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	Diagnostic Test: induced sputum Diagnostic Test: lung biopsy Diagnostic Test: bronchoalveolar lavage Diagnostic Test: blood draw	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Oct 27, 2022

Anticipated Primary Completion Date :

May 1, 2025

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Eosinophil detection Eosinophils will be measured in blood, sputum, bronchoalveolar lavage if available and biopsies.	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.

Arm

Intervention/Treatment

Experimental: Eosinophil detection

Eosinophils will be measured in blood, sputum, bronchoalveolar lavage if available and biopsies.

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Liège	Liège		Belgium	4000

Sponsors and Collaborators

Centre Hospitalier Universitaire de Liege

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anne Sibille, Dr Anne Sibille, Centre Hospitalier Universitaire de Liege

ClinicalTrials.gov Identifier:

NCT05602259

Other Study ID Numbers:

2022/258

First Posted:

Nov 2, 2022

Last Update Posted:

Nov 10, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Eosinophilia

Dimercaprol

Study Results

No Results Posted as of Nov 10, 2022