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Interaction Between Gut Microbiota and TKIs in Defining the Clinical Outcomes of Patients With CML

NCT06724536 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2024-12-09

No results posted yet for this study

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.

Conditions

  • Leukemia,Myeloid, Chronic

Interventions

OTHER

non interventional study with the use of biological samples.

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.

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Novartis

    collaborator INDUSTRY

  • Carmen Fava

    lead OTHER

Principal Investigators

  • Carmen Fava · Department of Clinical and Biological Sciences, University of Turin, Turin, Italy

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2026-10-01
Completion
2026-10-01

Countries

  • Italy

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06724536 on ClinicalTrials.gov