NCT01034059

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2008

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2009

Completed
Last Updated

December 17, 2009

Status Verified

December 1, 2009

Enrollment Period

8 months

First QC Date

December 16, 2009

Last Update Submit

December 16, 2009

Conditions

Eligibility Criteria

Age18 Years - 84 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with hematological malignancy developing neutropenic fever after chemotherapy

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Febrile Neutropenia

Condition Hierarchy (Ancestors)

NeutropeniaAgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Study Officials

  • Szu-Chun Hsu, MD

    Department of Laboratory Medicine, National Taiwan University Hospital and College of Medicine, Taipei

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 16, 2009

First Posted

December 17, 2009

Study Start

October 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

December 17, 2009

Record last verified: 2009-12