Interaction Between Gut Microbiota and TKIs in Defining the Clinical Outcomes of Patients With CML
Interaction Between Gut Microbiota and Tyrosine Kinase Inhibitors in Defining the Clinical Outcomes of Patients With Chronic Myeloid Leukemia
Carmen Fava
100 participants
Oct 1, 2022
OBSERVATIONAL
Conditions
Summary
Gut microbiome (GM) is acquiring increasing importance in human health and disease. GM influences hematopoiesis and immune cells types differentiation. Patients with cancer are characterized by dysbiosis and compromised immunity. In the case of Chronic Myeloid Leukemia (CML), treatment with Tyrosine Kinase Inhibitors (TKIs) restores immunosurveillance; in particular deep molecular response (DMR) is associated with increased levels of NK and CD8+ Tcells. There is no literature on the effects of GM on CML outcomes. This project aims to identify a microbial signature associated with a higher probability of achieving DMR.
Eligibility
Inclusion Criteria5
- Age \> 18 years old
- Chronic Myeloid Leukemia Patients
- Any stage of the disease
- Exclusioni Criteria:
- none
Interventions
Patients will undergo to the follow evaluations: Gut microbiome on stool samples by NGS (16S rRNA gene amplicon sequencing); Markers of impaired intestinal permeability \[diaminoxidase (DAO), serum zonulin\], and markers of inflammation of the GI tract (fecal calprotectin); Plasma inflammatory indices, cytokines (by Luminex), markers of autoimmunity, and metabolic profile; Acquired and adaptive immunity by multiparametric flow cytometry on PB samples.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06724536