Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-02-26 @ 7:24 PM
Study NCT ID:
NCT04858594
Status:
TERMINATED
Last Update Posted:
2022-04-11
First Post:
2021-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Periodontitis and Blood Stream Infection in AML Patients Receiving Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D010518', 'term': 'Periodontitis'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Research samples of gingival sulcus fluid, saliva and serum will be collected at baseline. Additionally the blood will be collected weekly through day 28 (or discharge if sooner), and if the patient develops neutropenic fever NF. NF is defined as an oral temperature of ≥100.4°F combined with an absolute neutrophil count (ANC) of ≤0.5x10\\^9/L\\^10'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'PI left and research was stopped', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-04', 'studyFirstSubmitDate': '2021-04-21', 'studyFirstSubmitQcDate': '2021-04-21', 'lastUpdatePostDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Blood stream infections', 'timeFrame': 'Day 28 of chemotherapy', 'description': 'Number of participants experiencing Blood stream infections (BSI) by day 28 of chemotherapy'}], 'secondaryOutcomes': [{'measure': 'Number of participants with Neutropenic fever', 'timeFrame': 'Day 28 of chemotherapy', 'description': 'Number of participants experiencing Neutropenic fever (NF) by day 28 of chemotherapy'}, {'measure': 'Number of participants exposed to different antibiotics', 'timeFrame': 'Day 28 of chemotherapy', 'description': 'Number of participants with antibiotic exposure by day 28 of chemotherapy'}, {'measure': 'Length of hospitalization', 'timeFrame': 'Day 28 of chemotherapy', 'description': 'Number of days the patients were hospitalized'}, {'measure': 'Number of participants who died', 'timeFrame': 'Day 28 of chemotherapy', 'description': 'Number of participants who died by day 28 of chemotherapy'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['BSI', 'Periodontitis', 'AML'], 'conditions': ['Acute Myeloid Leukemia']}, 'descriptionModule': {'briefSummary': 'This is a prospective, observational study to establish the connection between periodontitis and BSI in AML patients planning to receive intensive chemotherapy.', 'detailedDescription': 'Once eligibility is confirmed, participants will undergo a specialized baseline periodontal examination, gingival sulcus microbiota sampling and saliva sample at baseline before starting chemotherapy.\n\nPatients will be separated into 2 cohorts, with periodontitis (Arm A) and without periodontitis (Arm B). All patients will receive standard oncologic supportive care including antibiotic prophylaxis. Serum samples will be obtained at baseline, at the onset of neutropenic fever, and weekly until day 28 or discharge (whichever sooner).\n\nStudy participation will continue during the duration of standard of care chemotherapy for 28 days or until discharge from hospital, whichever later.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Study entry is open to adult patients regardless of gender, race or ethnic background. While there will be every effort to seek out and include women and minority patients, the patient population is expected to be similar to that of other relapsed AML studies at the University Of Minnesota', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years\n* Diagnosis of AML, new diagnosis or relapsed/refractory disease\n* Planned intensive inpatient chemotherapy, defined as expected hospitalization for 4 weeks or longer\n* Sufficient time to perform periodontal examination and treatment by the end of day 1 of chemotherapy without delaying chemotherapy\n* Written informed consent prior to performance of any research related activities\n\nExclusion Criteria:\n\n* Unstable for transfer to the School of Dentistry\n* Fever at the time of enrollment\n* Documented blood stream infection at the time of enrollment\n* Inherited bleeding diathesis\n* Periodontitis requiring treatment before starting chemotherapy\n* ANC \\<0.5 x 10\\^9/L at the time of enrollment\n* Unstable for transfer to the School of Dentistry\n* Fever at the time of enrollment\n* Documented blood stream infection at the time of enrollment\n* Inherited bleeding diathesis\n* Periodontitis requiring treatment before starting chemotherapy'}, 'identificationModule': {'nctId': 'NCT04858594', 'briefTitle': 'Study of Periodontitis and Blood Stream Infection in AML Patients Receiving Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Masonic Cancer Center, University of Minnesota'}, 'officialTitle': 'Effect of Periodontitis on the Risk of Bloodstream Infection During Intensive Chemotherapy in Patients With Acute Myeloid Leukemia', 'orgStudyIdInfo': {'id': '2020LS191'}, 'secondaryIdInfos': [{'id': 'HM2020-37', 'type': 'OTHER', 'domain': 'University of Minnesota Masonic Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Arm A: with Periodontitis', 'description': 'Patients with periodontitis', 'interventionNames': ['Other: Planned Chemotherapy']}, {'label': 'Arm B: without Periodontitis', 'description': 'Patients without periodontitis', 'interventionNames': ['Other: Planned Chemotherapy']}], 'interventions': [{'name': 'Planned Chemotherapy', 'type': 'OTHER', 'description': 'standard oncologic supportive care including antibiotic prophylaxis', 'armGroupLabels': ['Arm A: with Periodontitis', 'Arm B: without Periodontitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Masonic Cancer Center, 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'}}}}