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Trial Title:
PROspective Trial on EOsinophilia in Non-Small Cell Lung Cancer (NSCLC).
NCT ID:
NCT05602259
Condition:
Non-small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Eosinophilia
Dimercaprol
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
induced sputum
Description:
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.
Arm group label:
Eosinophil detection
Intervention type:
Diagnostic Test
Intervention name:
lung biopsy
Description:
As per standard practice, biopsies will be taken from the primary tumour site or from a
metastatic site.
Arm group label:
Eosinophil detection
Intervention type:
Diagnostic Test
Intervention name:
bronchoalveolar lavage
Description:
When available, the remaining material from a patient's bronchoalveolar lavage will be
collected.
Arm group label:
Eosinophil detection
Intervention type:
Diagnostic Test
Intervention name:
blood draw
Description:
As per standard practice, blood will be drawn from patients before and during treatment.
Data on white blood cells will be collected.
Arm group label:
Eosinophil detection
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU de Liège
Address:
City:
Liège
Zip:
4000
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Anne Sibille, MD
Phone:
+3243237400
Email:
anne.sibille@chuliege.be
Contact backup:
Last name:
Aurore Cue Alvarez
Phone:
+3243235539
Email:
aurore.cuealvarez@chuliege.be
Start date:
October 27, 2022
Completion date:
May 1, 2025
Lead sponsor:
Agency:
Centre Hospitalier Universitaire de Liege
Agency class:
Other
Source:
Centre Hospitalier Universitaire de Liege
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05602259
