Gut Microbiota in Intestinal Barrier Damage in Acute Leukemia Patients Undergoing Inpatient Induction

Study Overview
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Brief Summary
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This is an observational study to collect stool, blood, and urine from acute leukemia patients undergoing induction chemotherapy in order to generate preliminary data regarding the association between microbiota and chemotherapy-induced gut barrier damage. This study consists of inpatient collections of blood, urine, and stool while the patients are undergoing inpatient induction therapy. Patients will not be scheduled for any additional procedures or testing beyond what is required for clinical care.

Official Title
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The Role of Gut Microbiota in Intestinal Barrier Damage in Acute Leukemia Patients Undergoing Inpatient Induction Chemotherapy

Conditions
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Chemotherapy-Induced Gut Barrier Damage, Acute Leukemia

Intervention / Treatment
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* Diagnostic Test: Observational: Stool Sample Collection
* Diagnostic Test: Observational: Blood Sample Collection
* Diagnostic Test: Observational: Urine Sample Collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (ages 18 - 99 years) undergoing inpatient induction chemotherapy for newly diagnosed or relapsed acute leukemia (myeloid or lymphoblastic). Any induction regimen (standard or experimental) with planned  4 weeks of inpatient stay Able to provide written voluntary consent before performance of any study related procedure.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AL Patients Undergoing Induction Chemotherapy<br>Adults undergoing inpatient induction chemotherapy for newly diagnosed/relapsed acute leukemia. | Diagnostic Test: Observational: Stool Sample Collection<br>* Observational: Stool Sample Collection - Samples will be collected on the day of the first dose of chemotherapy, then subsequently every Monday, Wednesday, Friday until Day 28 of chemotherapy, death, or discharge from the hospital, whichever occurs sooner.<br>Diagnostic Test: Observational: Blood Sample Collection<br>* Observational: Blood Sample Collection - Samples will be collected on the day of the first dose of chemotherapy, then subsequently every Monday, Wednesday, Friday until Day 28 of chemotherapy, death, or discharge from the hospital, whichever occurs sooner.<br>Diagnostic Test: Observational: Urine Sample Collection<br>* Observational: Urine Sample Collection - Samples will be collected on the day of the first dose of chemotherapy, then subsequently every Monday, Wednesday, Friday until Day 28 of chemotherapy, death, or discharge from the hospital, whichever occurs sooner.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of Gut Microbiota Composition and Diversity | Variation of gut microbiota composition and diversity, as determined by 16s rRNA sequencing of serial stool samples, during induction chemotherapy in acute leukemia patients. | Three times weekly until day 28 of chemotherapy. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of Gut Barrier Integrity | Variation of gut barrier integrity, as determined by serum levels of zonulin, I-FABP, and citrulline, during induction chemotherapy in acute leukemia patients | Three times weekly until day 28 of chemotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AL