An observational study in Non Small Cell Lung Cancer, sponsored by University Hospital, Grenoble. Completed at 1 site in France. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-01-17.
Sponsored by University Hospital, Grenoble · Observational
Immune checkpoints inhibitors (ICI) are becoming new standards of care for Non-Small Cell Lung Carcinoma (NSCLC) treatment. To date, no powerful predictive biomarker of response has been found.
The investigators hypothesize that metabolomics profile could represent a potent biomarker of response to ICI
Immune checkpoints inhibitors (ICI) are becoming new standards of care for Non-Small Cell Lung Carcinoma (NSCLC) treatment, both as first and second line of treatment. To date, no powerful predictive biomarker of response has been found. It has been recently shown that microbiota composition could dictate the ability of patients to respond to ICI. Since, the microbiota produces circulating metabolites that will subsequently act on immune system, the investigators hypothesized that metabolic signature, reflecting microbiota function, could represent a predictive biomarker of response to ICI.
Primary objective is to identify baseline metabolic signature (metabolomics analysis by Mass spectrometry) associated to ICI response. Secondary objectives are to link metabolic signature with microbiota composition (metagenomics analysis RNA 16S) and immune profile, and altogether with clinic response to ICI. Profile evolution (metabolic, metagenomics and immune) will be also analyzed at 2-month post ICI initiation and at tumor progression, if any.
In order to do so, the investigators thus plan to enroll 60 NSCLC patients treated by ICI as 1st, 2nd or 3rd line of treatment in CHUGA in 18 months. Blood as well feces will be collected prior to, and at 2 month following ICI treatment initiation as well as at progression. Will be excluded from this study, patients that have received antibiotic or corticotherapy 2 or 4 weeks before ICI initiation, respectively.
6,485 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,630 are open to participants now.
This study's enrollment of 62 is below the median of 161 across 948 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.
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The study cohort will include NSCLC patients treated by ICI as 1st, 2nd or 3rd line of treatment in Grenoble University Hospital (France) in 18 months. 60 NSCLC patients are anticipated to be enrolled in the study.
Exclusion Criteria:
20 patients in first line of treatment
Other: Immune signature in serum associated to the metabolic signature · Genetic: Meta-genomic signature of intestinal flora
40 patients in second and third line of treatment
Other: Immune signature in serum associated to the metabolic signature · Genetic: Meta-genomic signature of intestinal flora
Immune signature in serum associated to the metabolic signature
Meta-genomic signature of intestinal flora
Identification of the change from baseline Metabolic signature as predictive factor of the ICI response at 6 months or at the tumoral progression
To identify the link of the change from baseline of Metabolic signature in serum (metabolomics analysis performed using a Mass spectrometry) and the ICI response at 6 months or at the tumoral progression
Time frame: baseline, 6 months or tumoral progression
Identification of the link between the Meta-genomic and immune signatures and the metabolic signature at 6 months or at the tumoral progression
To identify the link between the Meta-genomic signature of intestinal flora (microbiota composition analysed by RNA 16 S) with the Immune signature in serum and the metabolic signature at 6 months or at the tumoral progression
Time frame: 6 months or tumoral progression
Identification of the link between the Meta-genomic and immune signatures and ICI response at 6 months or at the tumoral progression
To identify the link between the Meta-genomic signature of intestinal flora with the Immune signature in serum and the ICI response at 6 months or at the tumoral progression
Time frame: 6 months or tumoral progression
Description of the profile change of Meta-genomic signature
To describe the change from baseline of the Meta-genomic signature at 2 months or at the tumoral progression
Time frame: 2 months or tumoral progression
Description of the profile change of Immune signature at 2 months or at the tumoral progression
To describe the change from baseline of the Immune signature at 2 months or at the tumoral progression
Time frame: Baseline and 2 months or tumoral progression
Identification of the link between the profile change of meta-genomic signature and the ICI response at 2 months or at the tumoral progression
To identify the link between the profile change from baseline of meta-genomic signature and the ICI response at 2 months or at the tumoral progression
Time frame: Baseline and (2 months or tumoral progression)
Identification of change of immune signature and the ICI response at 2 months or at the tumoral progression
To identify the link between the profile change from baseline of immune signature and the ICI response at 2 months or at the tumoral progression
Time frame: Baseline and (2 months or tumoral progression)
Description of overall survival under ICI at 6 months or at the tumoral progression
To describe of the overall survival under ICI at 6 months or at the tumoral progression
Time frame: 6 months or tumoral progression
Description of the survival without progression under ICI at 6 months or at the tumoral progression
To describe the survival without progression under ICI at 6 months or at the tumoral progression
Time frame: 6 months or tumoral progression
Plan to share: No
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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
University Hospital, Grenoble