Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2026-02-22 @ 4:14 AM
Study NCT ID:
NCT02856204
Status:
COMPLETED
Last Update Posted:
2019-05-16
First Post:
2016-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Shotgun Sequencing in Diagnosing Febrile Neutropenia in Patients With Acute Myeloid Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Australia', 'Brazil', 'China']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D064147', 'term': 'Febrile Neutropenia'}], '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': 'D009503', 'term': 'Neutropenia'}, {'id': 'D000380', 'term': 'Agranulocytosis'}, {'id': 'D007970', 'term': 'Leukopenia'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-14', 'studyFirstSubmitDate': '2016-08-02', 'studyFirstSubmitQcDate': '2016-08-02', 'lastUpdatePostDateStruct': {'date': '2019-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of pathogens in patients with febrile neutropenia assessed by shotgun metagenomics', 'timeFrame': 'Up to 6 weeks', 'description': 'Will be compared to standard of care diagnostics in the detection of pathogens in patients with febrile neutropenia.'}, {'measure': 'Number and frequency of novel pathogens found', 'timeFrame': 'Up to 6 weeks'}, {'measure': 'Proportion of patients with any pathogen by the standard, where the shotgun did not indicate the presence of the pathogen', 'timeFrame': 'Up to 6 weeks'}, {'measure': 'Proportion of patients with false negative', 'timeFrame': 'Up to 6 weeks'}, {'measure': 'Proportion of patients with false positives', 'timeFrame': 'Up to 6 weeks'}, {'measure': 'Proportion of patients with mitochondrial DNA detected', 'timeFrame': 'Up to 6 weeks'}], 'secondaryOutcomes': [{'measure': 'Microbiological diagnosis with known or unknown pathogens in patients in whom standard care failed to yield a pathogenic diagnosis assessed by shotgun metagenomics', 'timeFrame': 'Up to 6 weeks'}]}, 'conditionsModule': {'conditions': ['Acute Myeloid Leukemia', 'Febrile Neutropenia']}, 'descriptionModule': {'briefSummary': 'This research trial studies the shotgun sequencing of blood samples in diagnosing febrile neutropenia in patients with acute myeloid leukemia. Studying samples of blood from patients with acute myeloid leukemia in the laboratory may help identify pathogens and accurately diagnose infections such as febrile neutropenia.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To test the hypothesis that shotgun metagenomics is not inferior to standard of care diagnostics in the detection of pathogens in patients with febrile neutropenia.\n\nSECONDARY OBJECTIVES:\n\nI. To establish a microbiological diagnosis with known or unknown pathogens in patients in whom standard care failed to yield a pathogenic diagnosis.\n\nOUTLINE:\n\nPatients undergo collection of blood samples before and during the episode of febrile neutropenia for up to 6 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'hospitalized patients (at Stanford Hospital and Clinics) with acute myelogenous leukemia (AML), who are expected to have neutropenia (defined as absolute neutrophil count \\< 500 / cubic mm) lasting ≥ 7 days after chemotherapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with febrile neutropenia\n* A primary diagnosis of acute myeloid leukemia (AML)\n\nExclusion Criteria:\n\n* Prior history of febrile neutropenia'}, 'identificationModule': {'nctId': 'NCT02856204', 'briefTitle': 'Shotgun Sequencing in Diagnosing Febrile Neutropenia in Patients With Acute Myeloid Leukemia', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Shotgun Sequencing for Etiologic Diagnosis of Febrile Neutropenia', 'orgStudyIdInfo': {'id': 'HEMAML0035'}, 'secondaryIdInfos': [{'id': 'NCI-2016-01128', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '32817', 'type': 'OTHER', 'domain': 'Stanford IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Diagnostic (collection of blood samples)', 'description': 'Patients undergo collection of blood samples before and during the episode of febrile neutropenia for up to 6 weeks.', 'interventionNames': ['Other: Cytology Specimen Collection Procedure', 'Other: Laboratory Biomarker Analysis']}], 'interventions': [{'name': 'Cytology Specimen Collection Procedure', 'type': 'OTHER', 'otherNames': ['Cytologic Sampling'], 'description': 'Undergo collection of blood', 'armGroupLabels': ['Diagnostic (collection of blood samples)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Diagnostic (collection of blood samples)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University, School of Medicine', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Stanley Deresinski', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}, {'name': 'Steven Coutre', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}