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Microbiota Changes in Acute Myeloid Leukemia Patients Undergoing Intensive Chemotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03728699
Recruitment Status : Active, not recruiting
First Posted : November 2, 2018
Last Update Posted : May 18, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Acute Myeloid Leukemia Diagnostic Test: Sample Collection Blood Diagnostic Test: Stool Sample

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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 : January 2, 2018
Estimated Primary Completion Date : February 2025
Estimated Study Completion Date : February 2025



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


Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with acute myeloid leukemia (new diagnosis, refractory, or relapsed) undergoing any intensive chemotherapy with expected inpatient stay of ~4 weeks.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728699


Locations
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United States, Minnesota
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
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Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT03728699    
Other Study ID Numbers: 2018NTLS107
HM2018-23 ( Other Identifier: University of Minnesota Masonic Cancer Center )
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: May 18, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms