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Assessment of sTREM-1 as a Diagnostic Marker in Patients With Neutropenic Fever

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01034059
First Posted: December 17, 2009
Last Update Posted: December 17, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Taiwan University Hospital
  Purpose
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.

Condition
Neutropenic Fever

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of sTREM-1 as a Diagnostic Marker in Patients With Neutropenic Fever

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Biospecimen Retention:   Samples With DNA
whole blood

Enrollment: 75
Study Start Date: October 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 84 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with hematological malignancy developing neutropenic fever after chemotherapy
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • prolonged fever before presenting for admission,
  • antibiotics therapy in the past 72 hours,
  • more than two sites of infectious focus,
  • concomitant solid organ malignancy and blast in hemogram.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01034059


Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Szu-Chun Hsu, MD Department of Laboratory Medicine, National Taiwan University Hospital and College of Medicine, Taipei
  More Information

Responsible Party: Szu-Chun Hsu, Department of Laboratory Medicine, National Taiwan University Hospital and College of Medicine, Taipei
ClinicalTrials.gov Identifier: NCT01034059     History of Changes
Other Study ID Numbers: 200806051R
First Submitted: December 16, 2009
First Posted: December 17, 2009
Last Update Posted: December 17, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
Fever
Febrile Neutropenia
Body Temperature Changes
Signs and Symptoms
Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases