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NCT03728699 Clinical Trial

Microbiota Changes in Acute Myeloid Leukemia Patients Undergoing Intensive Chemotherapy

Acute Myeloid Leukemia Clinical Trial

Official title:
Microbiota Changes in Acute Myeloid Leukemia Patients Undergoing Intensive Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03728699
Other study ID # 2018NTLS107
Secondary ID HM2018-23
Status Completed
Phase
First received
Last updated
Start date January 2, 2018
Est. completion date February 18, 2022

Study information
Verified date November 2023
Source Masonic Cancer Center, University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a prospective, observational study to collect stool and blood from acute myeloid leukemia patients undergoing intensive chemotherapy.

Recruitment information / eligibility
Status Completed
Enrollment 54
Est. completion date February 18, 2022
Est. primary completion date May 17, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Adults (ages 18 - 99 years) undergoing inpatient intensive chemotherapy for newly diagnosed, refractory, or relapsed AML. Patients may or may not have been exposed to any type of therapy before. - Any intensive chemotherapy regimen defined as a planned ~4 week inpatient stay. Chemotherapy may be delivered for any number of days and on any schedule. Patients may be discharged from the hospital sooner than 4 weeks if the treating physician choose so, but the expectation at the initiation of chemotherapy must be ~4 weeks of inpatient stay, as is typical. - Able to provide written voluntary consent before performance of any study related procedure.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Sample Collection Blood
Collected from each patient twice weekly.
• Stool Sample
Collected from each patient twice weekly.

Locations
Country Name City State
United States Masonic Cancer Center at University of Minnesota Minneapolis Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Abundance of Phyla Abundance in stool and circulating microbiota during intensive chemotherapy in patients with acute myeloid leukemia (AML), measured by16S rRNA gene profiling of biospecimens using the Illumina MiSeq platform Day 28
Primary Abundance of Genera Abundance in stool and circulating microbiota during intensive chemotherapy in patients with acute myeloid leukemia (AML), measured by16S rRNA gene profiling of biospecimens using the Illumina MiSeq platform Day 28
Secondary Circulating Microbiota Diversity (Blood) Describe circulating microbiota diversity over the course of treatment Day 28
Secondary Microbiota Diversity (Stool) Describe stool microbiota diversity over the course of treatment Day 28
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