NCT06244355

Brief Summary

The objective is to study the phenotypic, functional and metabolomic characteristics of neutrophils circulating subpopulations in lung cancer patients, and to compare them to a control group of healthy volunteers. A blood sample will be taken before the first treatment session for the lung cancer patient and a second blood sample will be taken during the first evaluation visit. The investigators hypothesize that there may be different circulating neutrophil subpopulations in patients with metastatic non-small cell lung cancer (NSCLC) involved in tumor progression and resistance to immunotherapy.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
16mo left

Started Feb 2024

Typical duration for all trials

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

Study Progress65%
Feb 2024Dec 2027

First Submitted

Initial submission to the registry

October 27, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 6, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

February 12, 2024

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

3.3 years

First QC Date

October 27, 2023

Last Update Submit

March 4, 2026

Conditions

Lung Cancer

Keywords

Neutrophilsneutrophil subsetsAdvanced lung cancerbiomarkersPD-1 immunotherapyChronic inflammationPhenotypic modulationSpectral cytometry

Outcome Measures

Primary Outcomes (1)

  • Presence of a subpopulation of circulating neutrophils

    Presence of a subpopulation of circulating neutrophils in patients with lung cancer (absent in healthy volunteers and COPD patients) with phenotypic CD45+, CD15+, CD16+, CD62L-, LOX1+ and functional immunosuppressive characteristics.

    Through study completion, an average of 3 years

Secondary Outcomes (9)

  • Demographic characteristics

    Day 1

  • Performans status

    Day 1

  • Stage

    Day 1

  • Histologic type

    Day 1

  • Mutation status

    Day 1

  • +4 more secondary outcomes

Study Arms (3)

Lung cancer

Metastatic, with complete mutational status, without anterior treatment

Other: Extra blood tubes

Chronic obstructive pulmonary disease (COPD)

Diagnosis of post-smoking COPD (without diagnosis of CP)

Other: Extra blood tubes

Healthy volunteers

Healthy volunteers (based on biological and clinical data already available from the partner)

Other: Extra blood tubes

Interventions

Extra blood tubesOTHER

Extra blood tubes

Chronic obstructive pulmonary disease (COPD)Healthy volunteersLung cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with metastatic lung cancer, without anterior treatment. Inclusion during a consultation or hospitalization by a pneumologist or oncologist in the thoracic oncology unit during care.

You may qualify if:

  • Age ≥ 18 years,
  • male or female,
  • affiliated with a Health Insurance,
  • \- Diagnosis of metastatic stage lung cancer with mutation status, naïve treatment
  • \- Diagnosis of COPD post-smoking

You may not qualify if:

  • Tuberculosis or other acute or chronic bacterial infections
  • Chronic progressive viral infections (Hepatitis B and C, HIV)
  • Previous or ongoing chemotherapy
  • Impossibility of giving the subject informed information.
  • Opposition to the research.
  • Vulnerable individual (pregnant, parturient or breastfeeding woman), persons under guardianship or curatorship, or deprived of liberty by a judicial or administrative decision)
  • Patients benefiting from the AME

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique - Hôpitaux de Paris (AP-HP) - Cochin Hospital - Pneumology unit

Paris, Île-de-France Region, 75014, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Marie WISLEZ, Pr

    Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie WISLEZ, Pr

CONTACT

+33 1 58 41 18 89marie.wislez@aphp.fr

Marie BENHAMMANI-GODARD

CONTACT

+33 1 58411190marie.godard@aphp.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2023

First Posted

February 6, 2024

Study Start

February 12, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)