Ignite Creation Date:
2025-12-24 @ 2:05 PM
Ignite Modification Date:
2025-12-30 @ 5:43 PM
Study NCT ID:
NCT01622595
Status:
WITHDRAWN
Last Update Posted:
2015-10-27
First Post:
2012-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UARK 2009-99 A Non-interventional Observational Study of Infectious Complications in Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001228', 'term': 'Aspergillosis'}, {'id': 'D058387', 'term': 'Candidemia'}, {'id': 'D002177', 'term': 'Candidiasis'}, {'id': 'D007251', 'term': 'Influenza, Human'}], 'ancestors': [{'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D058365', 'term': 'Candidiasis, Invasive'}, {'id': 'D000072742', 'term': 'Invasive Fungal Infections'}, {'id': 'D016469', 'term': 'Fungemia'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D009976', 'term': 'Orthomyxoviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Principal Investigator has left the institution.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-26', 'studyFirstSubmitDate': '2012-06-15', 'studyFirstSubmitQcDate': '2012-06-18', 'lastUpdatePostDateStruct': {'date': '2015-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To study the incidence, risk factors, clinical presentation, diagnosis and prognostic factors of infectious complications in cancer patients', 'timeFrame': '3 years', 'description': 'To study the incidence, risk factors, clinical presentation, diagnosis and prognostic factors of infectious complications in cancer patients'}], 'secondaryOutcomes': [{'measure': 'incidence', 'timeFrame': '3 years', 'description': 'To determine the overall incidence of different infections, including bacterial, fungal and viral infections in cancer patients receiving chemotherapy and / or hematopoietic stem cell transplantation.\n\n* To describe the natural history of such infections in cancer patients.\n* To monitor the adherence of Myeloma institute for research and therapy(MIRT) health care workers to the MIRT standard operational procedures (SOPs)\n* To identify risk factors for the development of specific infections.\n* To validate surrogate markers as early diagnostic tools for various infections.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Aspergillosis', 'Candidemia', 'Candidiasis', 'C. Difficile', 'cytomegalovirus', 'respiratory syncytial virus (RSV)', 'Influenza', 'CONS'], 'conditions': ['Aspergillosis', 'Candidemia', 'C. Difficile']}, 'descriptionModule': {'briefSummary': 'OBSERVATIONAL STUDY OF INFECTIOUS COMPLICATIONS IN CANCER PATIENTS', 'detailedDescription': 'A NON-INTERVENTIONAL, OBSERVATIONAL STUDY OF INFECTIOUS COMPLICATIONS IN CANCER PATIENTS'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'cancer patients with Infections', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cancer patients with Infections\n\nExclusion Criteria:\n\n* No Infections'}, 'identificationModule': {'nctId': 'NCT01622595', 'briefTitle': 'UARK 2009-99 A Non-interventional Observational Study of Infectious Complications in Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Arkansas'}, 'officialTitle': 'A Non-interventional Observational Study of Infectious Complications in Cancer Patients', 'orgStudyIdInfo': {'id': '112265'}}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}], 'overallOfficials': [{'name': 'Senu Apewokin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UAMS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arkansas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}