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| ID | Type | Description | Link |
|---|---|---|---|
| HM2017-21 | Other Identifier | University of Minnesota Division of Hematology, Oncology and Transplantation |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AL Patients Undergoing Induction Chemotherapy | Adults undergoing inpatient induction chemotherapy for newly diagnosed/relapsed acute leukemia. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational: Stool Sample Collection | Diagnostic Test | 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. |
| 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. |
| 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 |
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Inclusion Criteria:
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Acute leukemia population at the University of Minnesota
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| Name | Affiliation | Role |
|---|---|---|
| Armin Rashidi, MD, PhD | Masonic Cancer Center, University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35192686 | Derived | Rashidi A, Ebadi M, Rehman TU, Elhusseini H, Halaweish HF, Kaiser T, Holtan SG, Khoruts A, Weisdorf DJ, Staley C. Lasting shift in the gut microbiota in patients with acute myeloid leukemia. Blood Adv. 2022 Jun 14;6(11):3451-3457. doi: 10.1182/bloodadvances.2021006783. | |
| 34478486 | Derived | Rashidi A, Ebadi M, Rehman TU, Elhusseini H, Nalluri H, Kaiser T, Ramamoorthy S, Holtan SG, Khoruts A, Weisdorf DJ, Staley C. Altered microbiota-host metabolic cross talk preceding neutropenic fever in patients with acute leukemia. Blood Adv. 2021 Oct 26;5(20):3937-3950. doi: 10.1182/bloodadvances.2021004973. |
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| Observational: Blood Sample Collection | Diagnostic Test | 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. |
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| Observational: Urine Sample Collection | Diagnostic Test | 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. |
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