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

University Hospital Center (CHU) of Liege

Status: Enrolling

Conditions: Non-small Cell Lung Cancer

Treatments: Diagnostic Test: induced sputum; Diagnostic Test: lung biopsy; Diagnostic Test: blood draw; Diagnostic Test: bronchoalveolar lavage

Study type: Interventional

Funder types: Other

Identifiers

NCT05602259

2022/258

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Eosinophil detection

Experimental group

Description:

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

Treatment:

Diagnostic Test: lung biopsy

Diagnostic Test: induced sputum

Diagnostic Test: blood draw

Diagnostic Test: bronchoalveolar lavage