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OpenTrials
Completed

NCT Number: NCT03728699

Microbiota Changes in Acute Myeloid Leukemia Patients Undergoing Intensive Chemotherapy

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

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sample Collection Blood

Diagnostic Test

Collected from each patient twice weekly.

Stool Sample

Diagnostic Test

Collected from each patient twice weekly.

Primary outcomes

  1. Abundance of Phyla

    Time frame: 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

    Time frame: 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 outcomes

  1. Circulating Microbiota Diversity (Blood)

    Time frame: Day 28

    Describe circulating microbiota diversity over the course of treatment

  2. Microbiota Diversity (Stool)

    Time frame: Day 28

    Describe stool microbiota diversity over the course of treatment

Sponsors and collaborators

Lead sponsor

Masonic Cancer Center, University of Minnesota

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Nov 2, 2018
Registry last updated
Nov 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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