NCT05602259

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable nonsmall-cell-lung-cancer

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

October 27, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 2, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

February 9, 2024

Status Verified

February 1, 2024

Enrollment Period

2.5 years

First QC Date

October 27, 2022

Last Update Submit

February 8, 2024

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Detection of eosinophils in untreated non-small cell lung cancer patients

    Concentration of eosinophils will be used in various bodily materials as described above.

    Baseline (pre-treatment)

Secondary Outcomes (1)

  • Prognostic and predictive value of eosinophils in non-small cell lung cancer patients

    Baseline (pre-treatment) and, if immunotherapy, after 3 months of treatment

Study Arms (1)

Eosinophil detection

EXPERIMENTAL

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

Diagnostic Test: induced sputumDiagnostic Test: lung biopsyDiagnostic Test: bronchoalveolar lavageDiagnostic Test: blood draw

Interventions

induced sputumDIAGNOSTIC_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.

Eosinophil detection
lung biopsyDIAGNOSTIC_TEST

As per standard practice, biopsies will be taken from the primary tumour site or from a metastatic site.

Eosinophil detection
bronchoalveolar lavageDIAGNOSTIC_TEST

When available, the remaining material from a patient's bronchoalveolar lavage will be collected.

Eosinophil detection
blood drawDIAGNOSTIC_TEST

As per standard practice, blood will be drawn from patients before and during treatment. Data on white blood cells will be collected.

Eosinophil detection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • o All stages of NSCLC
  • Stage III-IV NSCLC eligible for ICI treatment
  • 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

You may not qualify if:

  • Probable noncompliance with the follow-up requirements of the study (psychiatric condition, socio-economic factors)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Liège

Liège, 4000, Belgium

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Anne Sibille, MD

CONTACT

+3243237452anne.sibille@chuliege.be

Aurore Cue Alvarez

CONTACT

+3243235539aurore.cuealvarez@chuliege.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Anne Sibille

Study Record Dates

First Submitted

October 27, 2022

First Posted

November 2, 2022

Study Start

October 27, 2022

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

February 9, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)