Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-25 @ 10:24 PM
Study NCT ID:
NCT01034059
Status:
COMPLETED
Last Update Posted:
2009-12-17
First Post:
2009-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of sTREM-1 as a Diagnostic Marker in Patients With Neutropenic Fever
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D064147', 'term': 'Febrile Neutropenia'}], 'ancestors': [{'id': 'D009503', 'term': 'Neutropenia'}, {'id': 'D000380', 'term': 'Agranulocytosis'}, {'id': 'D007970', 'term': 'Leukopenia'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007960', 'term': 'Leukocyte Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-16', 'studyFirstSubmitDate': '2009-12-16', 'studyFirstSubmitQcDate': '2009-12-16', 'lastUpdatePostDateStruct': {'date': '2009-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Neutropenic Fever']}, 'descriptionModule': {'briefSummary': 'The soluble triggering receptor expressed on myeloid cells-1 (sTREM-1) was an established biomarker useful for infection in non-neutropenic patients. In this study, we tested sTREM-1 in the patients with neutropenic fever. Pro-calcitonin (PCT) and C-reactive protein (CRP) were also measured. We planned to investigate and explore the role of sTREM-1 in early diagnosis of infection in patients with neutropenic fever.', 'detailedDescription': 'Patients with hematological malignancies developed neutropenia after chemotherapy. We checked the serum level of sTREM-1 in patients with neutropenic fever. Those patients were classified to 2 groups: documented infection or low likelihood of infection. Their sTREM-1 level was measured and was compared with other biomarker such as CRP and procalcitonin. The value of sTREM-1 for diagnosis of infection in patients with neutropenic fever was thus evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '84 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with hematological malignancy developing neutropenic fever after chemotherapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chemotherapy-related neutropenia (granulocytes \\< 0.5 × 109/l or leukocytes \\< 1 × 109/l) and fever (body temperature \\> 38.0°C over a 6 hour observation period or body temperature ≥ 38.5°C once.\n\nExclusion Criteria:\n\n* prolonged fever before presenting for admission,\n* antibiotics therapy in the past 72 hours,\n* more than two sites of infectious focus,\n* concomitant solid organ malignancy and blast in hemogram.'}, 'identificationModule': {'nctId': 'NCT01034059', 'briefTitle': 'Assessment of sTREM-1 as a Diagnostic Marker in Patients With Neutropenic Fever', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Assessment of sTREM-1 as a Diagnostic Marker in Patients With Neutropenic Fever', 'orgStudyIdInfo': {'id': '200806051R'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Szu-Chun Hsu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Laboratory Medicine, National Taiwan University Hospital and College of Medicine, Taipei'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Szu-Chun Hsu', 'oldOrganization': 'Department of Laboratory Medicine, National Taiwan University Hospital and College of Medicine, Taipei'}}}}