Microbiota Changes in Acute Myeloid Leukemia Patients Undergoing Intensive Chemotherapy

• Sponsor: Masonic Cancer Center, University of Minnesota (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT03728699
• Collaborator: (none)
• Enrollment: 54
• Location: 1
• Anticipated Duration (Months): 85
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia	Diagnostic Test: Sample Collection Blood; Diagnostic Test: Stool Sample

Study Design

• Study Type: Observational
• Actual Enrollment: 54 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Microbiota Changes in Acute Myeloid Leukemia Patients Undergoing Intensive Chemotherapy
• Actual Study Start Date: Jan 2, 2018
• Anticipated Primary Completion Date: Feb 1, 2025
• Anticipated Study Completion Date: Feb 1, 2025

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

1. Circulating Microbiota Diversity (Blood) [Day 28]

   Describe circulating microbiota diversity over the course of treatment

2. Microbiota Diversity (Stool) [Day 28]

   Describe stool microbiota diversity over the course of treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Masonic Cancer Center at University of Minnesota	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

• Masonic Cancer Center, University of Minnesota

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Masonic Cancer Center, University of Minnesota
• ClinicalTrials.gov Identifier: NCT03728699
• Other Study ID Numbers: 2018NTLS107; HM2018-23
• First Posted: Nov 2, 2018
• Last Update Posted: May 18, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Masonic Cancer Center, University of Minnesota: AML
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute

Study Results

No Results Posted as of May 18, 2021