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

July 29, 2025 updated by: University Hospital, Bordeaux

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Patients receiving G-CSF
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
Other: Patients without G-CSF
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Expression of different MDSC markers corresponding to the rate of the different MDSC subpopulations
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
Immunosuppressive and non immunosuppressive functions of the different populations of MDSC
At baseline, 3 weeks, 6 weeks, 12 weeks, 6 months, 12 months and 24 months (end of chemo-immunotherapy) or in case of relapse

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

October 9, 2024

First Submitted That Met QC Criteria

November 26, 2024

First Posted (Actual)

December 2, 2024

Study Record Updates

Last Update Posted (Actual)

July 30, 2025

Last Update Submitted That Met QC Criteria

July 29, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2023/54

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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