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

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. Identifier: NCT01144793
Recruitment Status : Completed
First Posted : June 16, 2010
Last Update Posted : December 28, 2016
Theranos, Inc.
Information provided by (Responsible Party):
Jason Robert Gotlib, Stanford University

Brief Summary:
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.

Condition or disease
Leukemia, Lymphocytic Leukemia, Myeloid

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 17 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot/Observational Study Using a Biomarker Monitoring System to Evaluate Protein Profiles of Neutropenic Fever/Infection in Patients With Acute or Chronic Leukemias Undergoing Chemotherapy or Other Biologic Treatment
Study Start Date : April 2008
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever Leukemia
U.S. FDA Resources

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Acute or Chronic Leukemias

Inclusion Criteria:- Age >= 18

  • 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.

There are no exclusion criteria. Anyone who does not meet inclusion criteria will be excluded.

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 identifier (NCT number): NCT01144793

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Theranos, Inc.
Principal Investigator: Jason Robert Gotlib Stanford University

Publications of Results:
Responsible Party: Jason Robert Gotlib, Professor of Medicine, Stanford University Identifier: NCT01144793     History of Changes
Other Study ID Numbers: HEM0008
98712 ( Other Identifier: Stanford University Alternate IRB Approval Number )
SU-07102008-1246 ( Other Identifier: Stanford University )
12769 ( Other Identifier: Stanford IRB )
First Posted: June 16, 2010    Key Record Dates
Last Update Posted: December 28, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Lymphoid
Febrile Neutropenia
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukocyte Disorders
Hematologic Diseases