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Biomarker To Evaluate Protein Profiles of Neutropenic Fever/Infection With Acute or Chronic Leukemias

NCT ID: NCT01144793

Last Updated: 2016-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-06-30

Brief Summary

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The purpose of this study is to measure, in pilot/observational study, panels of circulating proteins in real time at the onset of neutropenic fever/infection in patients with acute or chronic leukemias undergoing chemotherapy or other biologic treatment. And to generate preliminary trend results in panels of circulating proteins longitudinally during the period of neutropenia and to correlate those values to clinical/laboratory data and patient outcomes.

Detailed Description

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To identify potential biomarkers for the prediction of NF, we performed serial measurements of nine biomarkers \[C-reactive protein (CRP), protein C, interleukin (IL)-6, IL-8, IL-10, IL-1β, tumor necrosis factor-α, monocyte chemotactic protein-1, and intercellular adhesion molecule-1\] using a multiplex ELISA array platform every 6-8 hours in patients undergoing myelosuppressive chemotherapy for hematologic malignancies.

Conditions

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Leukemia, Lymphocytic Leukemia, Myeloid

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Pre-admission (ATU, ITA) or inpatient status
* absolute neutrophil count (ANC) \<= 1500/mm\^3
* Patients with acute myeloid or lymphoid leukemia who:

* are admitted with newly diagnosed disease and have not yet received induction chemotherapy
* are admitted with neutropenic fever after receiving post-remission chemotherapy or are admitted for post-remission chemotherapy
* Patients with chronic myeloid leukemia or a chronic lymphoid leukemia/disorder who have received chemotherapy or other disease-specific treatment in the last 30 days where the ANC of \<=1500/mm3 is considered by the treating physician to be at least possibly treatment-related
* An intravenous line or catheter (Hickman, port, portacath, or peripherally inserted central venous catheter \[PICC\] line) must be in place at the time of protocol participation/study start, but will not be inserted solely for the purposes of the study.
* Whenever possible, patients will be consented and blood monitoring will be initiated before the first dose of antibiotic, but if not possible, at no time will standard of care measures will be delayed or interrupted for the purposes of study enrollment.
* Patients must be able to understand the nature of the study and give written informed consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Theranos, Inc.

INDUSTRY

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Jason Robert Gotlib

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jason Robert Gotlib

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

References

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Chan SM, Chadwick J, Young DL, Holmes E, Gotlib J. Intensive serial biomarker profiling for the prediction of neutropenic Fever in patients with hematologic malignancies undergoing chemotherapy: a pilot study. Hematol Rep. 2014 Jun 23;6(2):5466. doi: 10.4081/hr.2014.5466. eCollection 2014 Apr 22.

Reference Type RESULT
PMID: 25013718 (View on PubMed)

Other Identifiers

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98712

Identifier Type: OTHER

Identifier Source: secondary_id

SU-07102008-1246

Identifier Type: OTHER

Identifier Source: secondary_id

12769

Identifier Type: OTHER

Identifier Source: secondary_id

HEM0008

Identifier Type: -

Identifier Source: org_study_id