Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-02-04 @ 3:56 PM
Study NCT ID:
NCT03316456
Status:
COMPLETED
Last Update Posted:
2019-05-06
First Post:
2017-10-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gut Microbiota in Intestinal Barrier Damage in Acute Leukemia Patients Undergoing Inpatient Induction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-02', 'studyFirstSubmitDate': '2017-10-11', 'studyFirstSubmitQcDate': '2017-10-17', 'lastUpdatePostDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variation of Gut Microbiota Composition and Diversity', 'timeFrame': 'Three times weekly until day 28 of chemotherapy.', 'description': 'Variation of gut microbiota composition and diversity, as determined by 16s rRNA sequencing of serial stool samples, during induction chemotherapy in acute leukemia patients.'}], 'secondaryOutcomes': [{'measure': 'Variation of Gut Barrier Integrity', 'timeFrame': 'Three times weekly until day 28 of chemotherapy', 'description': 'Variation of gut barrier integrity, as determined by serum levels of zonulin, I-FABP, and citrulline, during induction chemotherapy in acute leukemia patients'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AL'], 'conditions': ['Chemotherapy-Induced Gut Barrier Damage', 'Acute Leukemia']}, 'referencesModule': {'references': [{'pmid': '35192686', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '34478486', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Acute leukemia population at the University of Minnesota', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (ages 18 - 99 years) undergoing inpatient induction chemotherapy for newly diagnosed or relapsed acute leukemia (myeloid or lymphoblastic).\n* Any induction regimen (standard or experimental) with planned \\~4 weeks of inpatient stay\n* Able to provide written voluntary consent before performance of any study related procedure.'}, 'identificationModule': {'nctId': 'NCT03316456', 'briefTitle': 'Gut Microbiota in Intestinal Barrier Damage in Acute Leukemia Patients Undergoing Inpatient Induction', 'organization': {'class': 'OTHER', 'fullName': 'Masonic Cancer Center, University of Minnesota'}, 'officialTitle': 'The Role of Gut Microbiota in Intestinal Barrier Damage in Acute Leukemia Patients Undergoing Inpatient Induction Chemotherapy', 'orgStudyIdInfo': {'id': '2017NTLS052'}, 'secondaryIdInfos': [{'id': 'HM2017-21', 'type': 'OTHER', 'domain': 'University of Minnesota Division of Hematology, Oncology and Transplantation'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'AL Patients Undergoing Induction Chemotherapy', 'description': 'Adults undergoing inpatient induction chemotherapy for newly diagnosed/relapsed acute leukemia.', 'interventionNames': ['Diagnostic Test: Observational: Stool Sample Collection', 'Diagnostic Test: Observational: Blood Sample Collection', 'Diagnostic Test: Observational: Urine Sample Collection']}], 'interventions': [{'name': 'Observational: Stool Sample Collection', 'type': 'DIAGNOSTIC_TEST', 'description': 'Observational: Stool Sample Collection\n\n\\- 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.', 'armGroupLabels': ['AL Patients Undergoing Induction Chemotherapy']}, {'name': 'Observational: Blood Sample Collection', 'type': 'DIAGNOSTIC_TEST', 'description': 'Observational: Blood Sample Collection\n\n\\- 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.', 'armGroupLabels': ['AL Patients Undergoing Induction Chemotherapy']}, {'name': 'Observational: Urine Sample Collection', 'type': 'DIAGNOSTIC_TEST', 'description': 'Observational: Urine Sample Collection\n\n\\- 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.', 'armGroupLabels': ['AL Patients Undergoing Induction Chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Masonic Cancer Center at University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Armin Rashidi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Masonic Cancer Center, University of Minnesota'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Masonic Cancer Center, University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}