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

Not Applicable

Recruiting

• Conditions: Non-small Cell Lung Cancer
• Interventions: Diagnostic Test: induced sputum; Diagnostic Test: lung biopsy; Diagnostic Test: bronchoalveolar lavage; Diagnostic Test: blood draw

• Registration Number: NCT05602259
• Lead Sponsor: Centre Hospitalier Universitaire de Liege

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-27
• Study First Submitted: 2022-10-27
• Study First Submitted QC: 2022-10-27
• Study First Posted: 2022-11-02
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-08
• Last Update Posted: 2024-02-09
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Eosinophil detection	induced sputum	Eosinophils will be measured in blood, sputum, bronchoalveolar lavage if available and biopsies.
Eosinophil detection	bronchoalveolar lavage	Eosinophils will be measured in blood, sputum, bronchoalveolar lavage if available and biopsies.
Eosinophil detection	lung biopsy	Eosinophils will be measured in blood, sputum, bronchoalveolar lavage if available and biopsies.
Eosinophil detection	blood draw	Eosinophils will be measured in blood, sputum, bronchoalveolar lavage if available and biopsies.

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

CHU de Liège; 🇧🇪 Liège, Belgium