Gut Microbiota in Intestinal Barrier Damage in Acute Leukemia Patients Undergoing Inpatient Induction

NCT ID: NCT03316456

Last Updated: 2019-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-22

Study Completion Date

2019-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is an observational study to collect stool, blood, and urine from acute leukemia patients undergoing induction chemotherapy in order to generate preliminary data regarding the association between microbiota and chemotherapy-induced gut barrier damage. This study consists of inpatient collections of blood, urine, and stool while the patients are undergoing inpatient induction therapy. Patients will not be scheduled for any additional procedures or testing beyond what is required for clinical care.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chemotherapy-Induced Gut Barrier Damage Acute Leukemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AL Patients Undergoing Induction Chemotherapy

Adults undergoing inpatient induction chemotherapy for newly diagnosed/relapsed acute leukemia.

Observational: Stool Sample Collection

Intervention Type DIAGNOSTIC_TEST

Observational: Stool Sample Collection

\- Samples will be collected on the day of the first dose of chemotherapy, then subsequently every Monday, Wednesday, Friday until Day 28 of chemotherapy, death, or discharge from the hospital, whichever occurs sooner.

Observational: Blood Sample Collection

Intervention Type DIAGNOSTIC_TEST

Observational: Blood Sample Collection

\- Samples will be collected on the day of the first dose of chemotherapy, then subsequently every Monday, Wednesday, Friday until Day 28 of chemotherapy, death, or discharge from the hospital, whichever occurs sooner.

Observational: Urine Sample Collection

Intervention Type DIAGNOSTIC_TEST

Observational: Urine Sample Collection

\- Samples will be collected on the day of the first dose of chemotherapy, then subsequently every Monday, Wednesday, Friday until Day 28 of chemotherapy, death, or discharge from the hospital, whichever occurs sooner.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Observational: Stool Sample Collection

Observational: Stool Sample Collection

\- Samples will be collected on the day of the first dose of chemotherapy, then subsequently every Monday, Wednesday, Friday until Day 28 of chemotherapy, death, or discharge from the hospital, whichever occurs sooner.

Intervention Type DIAGNOSTIC_TEST

Observational: Blood Sample Collection

Observational: Blood Sample Collection

\- Samples will be collected on the day of the first dose of chemotherapy, then subsequently every Monday, Wednesday, Friday until Day 28 of chemotherapy, death, or discharge from the hospital, whichever occurs sooner.

Intervention Type DIAGNOSTIC_TEST

Observational: Urine Sample Collection

Observational: Urine Sample Collection

\- Samples will be collected on the day of the first dose of chemotherapy, then subsequently every Monday, Wednesday, Friday until Day 28 of chemotherapy, death, or discharge from the hospital, whichever occurs sooner.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adults (ages 18 - 99 years) undergoing inpatient induction chemotherapy for newly diagnosed or relapsed acute leukemia (myeloid or lymphoblastic).
* Any induction regimen (standard or experimental) with planned \~4 weeks of inpatient stay
* Able to provide written voluntary consent before performance of any study related procedure.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Masonic Cancer Center, University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Armin Rashidi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, University of Minnesota

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Rashidi A, Ebadi M, Rehman TU, Elhusseini H, Halaweish HF, Kaiser T, Holtan SG, Khoruts A, Weisdorf DJ, Staley C. Lasting shift in the gut microbiota in patients with acute myeloid leukemia. Blood Adv. 2022 Jun 14;6(11):3451-3457. doi: 10.1182/bloodadvances.2021006783.

Reference Type DERIVED
PMID: 35192686 (View on PubMed)

Rashidi A, Ebadi M, Rehman TU, Elhusseini H, Nalluri H, Kaiser T, Ramamoorthy S, Holtan SG, Khoruts A, Weisdorf DJ, Staley C. Altered microbiota-host metabolic cross talk preceding neutropenic fever in patients with acute leukemia. Blood Adv. 2021 Oct 26;5(20):3937-3950. doi: 10.1182/bloodadvances.2021004973.

Reference Type DERIVED
PMID: 34478486 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HM2017-21

Identifier Type: OTHER

Identifier Source: secondary_id

2017NTLS052

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Nutrition Impact on Immunotherapy of Cancer
NCT06500234 RECRUITING PHASE3