Microbiota Changes in Acute Myeloid Leukemia Patients Undergoing Intensive Chemotherapy

Completed

• Conditions: Acute Myeloid Leukemia

• Registration Number: NCT03728699
• Lead Sponsor: Masonic Cancer Center, University of Minnesota

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-02
• Study First Submitted: 2018-10-31
• Study First Submitted QC: 2018-10-31
• Study First Posted: 2018-11-02
• Primary Completion: 2021-05-17
• Study Completion: 2022-02-18
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-02
• Last Update Posted: 2023-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Abundance of Phyla	Day 28	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
Abundance of Genera	Day 28	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

Secondary Outcome Measures

Name	Time	Method
Microbiota Diversity (Stool)	Day 28	Describe stool microbiota diversity over the course of treatment
Circulating Microbiota Diversity (Blood)	Day 28	Describe circulating microbiota diversity over the course of treatment

Trial Locations

Locations (1)

Masonic Cancer Center at University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States