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

U

University Hospital of Bordeaux

Status

Not yet enrolling

Conditions

Granulocyte Colony Stimulating Factor
Immunotherapy
Non Small Cell Lung Cancer

Treatments

Biological: Blood sample

Study type

Interventional

Funder types

Other

Identifiers

NCT06711770
CHUBX 2023/54

Details and patient eligibility

About

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.

Full 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

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

Patients receiving G-CSF
Other group
Treatment:
Biological: Blood sample
Patients without G-CSF
Other group
Treatment:
Biological: Blood sample

Trial contacts and locations

1

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Central trial contact

Nicolas LARMONIER; Charlotte DOMBLIDES

Data sourced from clinicaltrials.gov

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