Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2026-01-07 @ 5:23 AM
Study NCT ID:
NCT01254318
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2010-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessment of the Fungal Infection Incidence Across Canada for High Risk Participants With Hematological Disease (P07501)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The Principal Investigator and Institution agree to provide 45 days written notice to Sponsor prior to submission for publication or presentation to permit Sponsor to review drafts of abstracts and manuscripts for publication which report any results arising out of the Study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Adverse Events were not collected during this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Participants at High Risk for IFI', 'description': 'Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem cell transplantation.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Non-Candida Invasive Fungal Infections at a Single Institution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants at High Risk for IFI', 'description': 'Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem cell transplantation.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.3', 'groupId': 'OG000', 'lowerLimit': '24.4', 'upperLimit': '41.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '365 days', 'description': 'Data were extracted from participant hospital records from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of high risk participants with non-Candida invasive fungal infections.', 'unitOfMeasure': 'Percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received stem-cell transplant and high dose chemotherapy for leukemia.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With a Specific Fungal Pathogen at a Single Institution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants at High Risk for IFI', 'description': 'Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem cell transplantation.'}], 'classes': [{'title': 'Aspergillus', 'categories': [{'measurements': [{'value': '8.5', 'groupId': 'OG000'}]}]}, {'title': 'Fusarium', 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'Penicillium', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '21.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '365 days', 'description': 'Data were extracted from participant hospital records from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of participants with a specific fungal pathogen.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received stem cell transplant and high dose chemotherapy for leukemia.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Invasive Fungal Infections in Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants at High Risk for IFI', 'description': 'Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem cell transplantation.'}], 'timeFrame': '365 days', 'description': 'Data were to be extracted from participant hospital records from 5-9 centers across Canada starting from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of high risk participants with non-Candida invasive fungal infections.', 'reportingStatus': 'POSTED', 'populationDescription': 'Whereas enrollment at 5-9 centers in Canada was planned, this was not accomplished, as data were only collected from a single institution in Canada.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participants at High Risk for IFI', 'description': 'Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem cell transplantation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Alive at start of study', 'groupId': 'FG000', 'numSubjects': '130'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Alive at end of study', 'groupId': 'FG000', 'numSubjects': '78'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '52'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '47'}]}]}], 'recruitmentDetails': 'Participants with hematologic malignancy requiring high dose chemotherapy with or without stem cell transplant were selected from a single tertiary care center in Canada.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Participants at High Risk for IFI', 'description': 'Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem-cell transplantation.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.28', 'spread': '15.26', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '51', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '79', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-13', 'studyFirstSubmitDate': '2010-11-05', 'resultsFirstSubmitDate': '2016-09-13', 'studyFirstSubmitQcDate': '2010-12-03', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-09-13', 'studyFirstPostDateStruct': {'date': '2010-12-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Non-Candida Invasive Fungal Infections at a Single Institution', 'timeFrame': '365 days', 'description': 'Data were extracted from participant hospital records from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of high risk participants with non-Candida invasive fungal infections.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With a Specific Fungal Pathogen at a Single Institution', 'timeFrame': '365 days', 'description': 'Data were extracted from participant hospital records from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of participants with a specific fungal pathogen.'}, {'measure': 'Percentage of Participants With Invasive Fungal Infections in Canada', 'timeFrame': '365 days', 'description': 'Data were to be extracted from participant hospital records from 5-9 centers across Canada starting from the time of initiating chemotherapy or conditioning regimen for their stem cell transplant (index date) until one year post-index date, in order to determine the percentage of high risk participants with non-Candida invasive fungal infections.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hematological malignancy', 'fungal infection', 'leukemia'], 'conditions': ['Mycoses', 'Leukemia']}, 'descriptionModule': {'briefSummary': 'This will be a retrospective study that includes retrospective chart reviews at major institutions across Canada. The intent of the study is to generate both regional and national incidence data for non-Candida invasive fungal infections (IFI) in high risk participants. The study will include participants receiving stem cell transplant and high dose chemotherapy treatment for leukemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants at high risk for IFI at medical institutions in Canada', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To be eligible for study inclusion, the participant must have:\n* A hematological malignancy requiring high dose chemotherapy with or without bone marrow transplant\n\nExclusion Criteria:\n\n* The participant is not eligible for study inclusion if:\n* Their IFI is not related to hematological malignancies.'}, 'identificationModule': {'nctId': 'NCT01254318', 'acronym': 'TRAFIC', 'briefTitle': 'Assessment of the Fungal Infection Incidence Across Canada for High Risk Participants With Hematological Disease (P07501)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'Temporal Realistic Assessment of the Fungal Infection Incidence Across Canada for High Risk Subjects With Hematological Disease (TRAFIC)', 'orgStudyIdInfo': {'id': 'P07501'}, 'secondaryIdInfos': [{'id': 'MK-5592-071', 'type': 'OTHER', 'domain': 'Merck Protocol Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Participants at high risk for IFI', 'description': 'Participants will be considered high risk if they are undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants are also considered to be at high risk for IFI if they have undergone allogeneic hematopoietic stem-cell transplantation.', 'interventionNames': ['Other: Standard Care']}], 'interventions': [{'name': 'Standard Care', 'type': 'OTHER', 'description': 'Health-care interventions will be recorded; no additional procedures outside the standard of care will be required.', 'armGroupLabels': ['Participants at high risk for IFI']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'McGill University Health Centre/Research Institute of the McGill University Health Centre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}