Chemotherapy-Induced Gut Barrier DamageNCT03316456
Gut Microbiota in Intestinal Barrier Damage in Acute Leukemia Patients Undergoing Inpatient Induction
An observational study of Chemotherapy-Induced Gut Barrier Damage and Acute Leukemia, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chemotherapy-Induced Gut Barrier Damage, Acute Leukemia
- What is being tested?
- Observational: Stool Sample Collection, Observational: Blood Sample Collection and Observational: Urine Sample Collection
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 2017to 1 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute leukemia population at the University of Minnesota
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: The Role of Gut Microbiota in Intestinal Barrier Damage in Acute Leukemia Patients Undergoing Inpatient Induction Chemotherapy
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.
- Being tested
- Observational: Stool Sample Collection, Observational: Blood Sample Collection, Observational: Urine Sample Collection
- Keywords
- AL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational: Stool Sample CollectionDiagnostic 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 CollectionDiagnostic 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 CollectionDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| AL Patients Undergoing Induction Chemotherapy | Adults undergoing inpatient induction chemotherapy for newly diagnosed/relapsed acute leukemia. Receives: Diagnostic Test: Observational: Stool Sample Collection; Diagnostic Test: Observational: Blood Sample Collection; Diagnostic Test: Observational: Urine Sample Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of Gut Microbiota Composition and Diversity
Variation of gut microbiota composition and diversity, as determined by 16s rRNA sequencing of serial stool samples, during induction chemotherapy in acute leukemia patients.
Measured: Three times weekly until day 28 of chemotherapy.
Secondary outcomes (1)
Variation of Gut Barrier Integrity
Variation of gut barrier integrity, as determined by serum levels of zonulin, I-FABP, and citrulline, during induction chemotherapy in acute leukemia patients
Measured: Three times weekly until day 28 of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start22 Aug 2017
- Primary completion26 Dec 2017
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chemotherapy-Induced Gut Barrier DamageStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Armin Rashidi, MD, PhD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316456
- Sponsor's protocol ID
- 2017NTLS052
- Other IDs
- HM2017-21
- Status last verified
- May 2019
- First submitted
- 11 Oct 2017
- Last updated
- 6 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35192686Rashidi 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.
PubMed 34478486
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Gut Microbiota in Intestinal Barrier Damage in Acute Leukemia Patients Undergoing Inpatient Induction Chemotherapy
- ClinicalTrials.gov ID
- NCT03316456
- Acronym / sponsor ID
- 2017NTLS052
- Keywords
- AL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 22 Aug 2017 (actual)
- Primary completion
- 26 Dec 2017 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 20 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AL Patients Undergoing Induction Chemotherapy | – | Diagnostic Test: Observational: Stool Sample Collection, Diagnostic Test: Observational: Blood Sample Collection, Diagnostic Test: Observational: Urine Sample CollectionAdults undergoing inpatient induction chemotherapy for newly diagnosed/relapsed acute leukemia. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute leukemia population at the University of Minnesota
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational: Stool Sample CollectionObservational: 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. | Diagnostic test | AL Patients Undergoing Induction Chemotherapy |
| Observational: Blood Sample CollectionObservational: 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. | Diagnostic test | AL Patients Undergoing Induction Chemotherapy |
| Observational: Urine Sample CollectionObservational: 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. | Diagnostic test | AL Patients Undergoing Induction Chemotherapy |
Primary outcome
Variation of Gut Microbiota Composition and Diversity
Time frame: Three times weekly until day 28 of chemotherapy.
Variation of gut microbiota composition and diversity, as determined by 16s rRNA sequencing of serial stool samples, during induction chemotherapy in acute leukemia patients.
1 secondary outcome
Variation of Gut Barrier Integrity
Time frame: Three times weekly until day 28 of chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
- Derived from this study: PubMed 35192686Rashidi 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.
- Derived from this study: PubMed 34478486Rashidi 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Armin Rashidi, MD, PhD principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy-Induced Gut Barrier Damage and Acute Leukemia, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation of Gut Microbiota Composition and Diversity (time frame: Three times weekly until day 28 of chemotherapy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03316456, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2019.