Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date October 31, 2018
First Posted Date November 2, 2018
Last Update Posted Date May 18, 2021
Actual Study Start Date January 2, 2018
Estimated Primary Completion Date February 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 2, 2018)
  • 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
  • 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
Original Primary Outcome Measures
 (submitted: October 31, 2018)
  • Abundance of Phyla [ Time Frame: Day 28 ]
    Amount in stool and circulating microbiota during intensive chemotherapy in patients with acute myeloid leukemia (AML).
  • Abundance of Genera [ Time Frame: Day 28 ]
    Amount in stool and circulating microbiota during intensive chemotherapy in patients with acute myeloid leukemia (AML).
Change History
Current Secondary Outcome Measures
 (submitted: October 31, 2018)
  • Circulating Microbiota Diversity (Blood) [ Time Frame: Day 28 ]
    Describe circulating microbiota diversity over the course of treatment
  • Microbiota Diversity (Stool) [ Time Frame: Day 28 ]
    Describe stool microbiota diversity over the course of treatment
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Microbiota Changes in Acute Myeloid Leukemia Patients Undergoing Intensive Chemotherapy
Official Title Microbiota Changes in Acute Myeloid Leukemia Patients Undergoing Intensive Chemotherapy
Brief Summary This is a prospective, observational study to collect stool and blood from acute myeloid leukemia patients undergoing intensive chemotherapy.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Acute Myeloid Leukemia
Intervention
  • Diagnostic Test: Sample Collection Blood
    Collected from each patient twice weekly.
  • Diagnostic Test: Stool Sample
    Collected from each patient twice weekly.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: May 17, 2021)
54
Original Estimated Enrollment
 (submitted: October 31, 2018)
100
Estimated Study Completion Date February 2025
Estimated Primary Completion Date February 2025   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03728699
Other Study ID Numbers 2018NTLS107
HM2018-23 ( Other Identifier: University of Minnesota Masonic Cancer Center )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Masonic Cancer Center, University of Minnesota
Study Sponsor Masonic Cancer Center, University of Minnesota
Collaborators Not Provided
Investigators Not Provided
PRS Account Masonic Cancer Center, University of Minnesota
Verification Date May 2021