Acute Leukemia, Chemotherapy-Induced Gut Barrier Damage
Conditions
Keywords
AL
Brief summary
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.
Interventions
DIAGNOSTIC_TESTObservational: Stool Sample Collection
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.
DIAGNOSTIC_TESTObservational: Blood Sample Collection
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.
DIAGNOSTIC_TESTObservational: Urine Sample Collection
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.
Sponsors
Masonic Cancer Center, University of Minnesota
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Variation of Gut Microbiota Composition and Diversity | Three times weekly until day 28 of chemotherapy. | Variation of gut microbiota composition and diversity, as determined by 16s rRNA sequencing of serial stool samples, during induction chemotherapy in acute leukemia patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Variation of Gut Barrier Integrity | Three times weekly until day 28 of chemotherapy | Variation of gut barrier integrity, as determined by serum levels of zonulin, I-FABP, and citrulline, during induction chemotherapy in acute leukemia patients |
Countries
United States
Outcome results
None listed