Microbiota Changes in Acute Myeloid Leukemia Patients Undergoing Intensive Chemotherapy

NCT03728699 | Completed

• 2 other identifiers: 2018NTLS107HM2018-23
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Myeloid Leukemia

Keywords

AML

Outcome Measures

Primary Outcomes (2)

• Abundance of Phyla

  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

  Day 28

• Abundance of Genera

  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

  Day 28

Secondary Outcomes (2)

• Circulating Microbiota Diversity (Blood)

  Day 28

• Microbiota Diversity (Stool)

  Day 28

Interventions

Sample Collection Blood DIAGNOSTIC_TEST

Collected from each patient twice weekly.

Stool Sample DIAGNOSTIC_TEST

Collected from each patient twice weekly.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 2, 2018
• Study Start: January 2, 2018
• Primary Completion: May 17, 2021
• Study Completion: February 18, 2022
• Last Updated: November 3, 2023

Record last verified: 2023-11

Locations

US (1)