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Not yet recruiting NCT06711770

Effect of G-CSF on MDSC and Cancer Stem-cells Interactions in Non-small Cell Lung Cancers (CIRCUIT)

No phase Interventional Non Small Cell Lung Cancer Immunotherapy Granulocyte Colony Stimulating Factor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood sample.
Who it may be relevant to
Registry conditions: Non Small Cell Lung Cancer, Immunotherapy, Granulocyte Colony Stimulating Factor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Characterization of the Effect of G-CSF on the Interactions Between MDSC and Cancer Stem-cells in Non-small Cell Lung Cancers (CIRCUIT)

Overview

Immunotherapy have revolutionized the field of oncology, but response rates are low and all patients relapse, due to immunologic (myeloid immunosuppressive cells) and non-immunologic (cancer stem- cells (CSC)) mechanisms. CSC are able to circulate within blood, protected from destruction by immunosuppressive cells such as MDSC. Some factors such as G-CSF, administered to lower febrile neutropenia, should modulate properties of MDSC and CSC, but data are contradictory, and literature remain poor regarding its effects on the interactions between MDSC and CSC in blood clusters. Indeed, this project aims at better characterizing the effect of G-CSF on these interactions and on their functions in NSCLC patients receiving G-CSF.

Detailed description

MDSC, CSC and the clusters in blood from NSCLC patients will be assessed to evaluate the impact of G-CSF on their phenotype and functions. Samples from 2 groups of NSCLC patients receiving chemotherapy and immunotherapy will be used: 15 receiving concomitant G-CSF, and 15 not receiving concomitant G-CSF

Interventions

  • Biological Blood sample
    Four tubes of 7 mL collected at baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months and 24 months (end of chemo-immunotherapy) or in case of relapse

Primary outcome measures

  • Phenotype of MDSC and CSC [Time frame: At baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months and 24 months (end of chemo-immunotherapy) or in case of relapse]
  • Functions of MDSC and CSC [Time frame: At baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months and 24 months (end of chemo-immunotherapy) or in case of relapse]

Eligibility criteria

Inclusion criteria

  • Patients (male or female) aged ≥ 18 years
  • Histological or cytological proven lung adenocarcinoma, metastatic or locally advanced not accessible to local therapy
  • Receiving chemotherapy and immunotherapy as first-line treatment
  • Signed written informed consent (no later than the day of inclusion, and before the blood sample collection)
  • Patient affiliated or beneficiary to a health security system;

Exclusion criteria

  • Patient with a small cell lung carcinoma
  • Non-metastatic disease
  • Actionable mutation or genomic alteration in EGFR, ALK or ROS1
  • Corticosteroids > 10 mg/j
  • Autoimmune disease
  • Active and uncontrolled HIV infection
  • Concomitant cancer
  • Pregnancy or lactating women
  • Psychiatric or medical conditions that prohibit the understanding and rendering of informed consent
  • Patient under a legal protection measure
  • Patient with a deprived liberty condition
  • Patient incapable of giving signed informed consent
  • Patient within the exclusion period for another clinical trial, or participating to another interventional trial within 30 days before the beginning of this project

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

France · 1 center
  • CHU de Bordeaux, service d'Oncologie Médicale — Bordeaux

Identifiers

NCT: NCT06711770 · CHUBX 2023/54

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗