Clincosm LogoSign in Get a demo

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

Sponsor
Stanford University (Other)
Overall Status
Completed
CT.gov ID
NCT01144793
Collaborator
Theranos, Inc. (Industry)
17
Enrollment
1
Location
2
Duration (Months)
8.5
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    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 :
    Apr 1, 2008
    Actual Primary Completion Date :
    Jun 1, 2008
    Actual Study Completion Date :
    Jun 1, 2008

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No

      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.

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 Stanford University School of Medicine Stanford California United States 94305

      Sponsors and Collaborators

      • Stanford University
      • Theranos, Inc.

      Investigators

      • Principal Investigator: Jason Robert Gotlib, Stanford University

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Jason Robert Gotlib, Professor of Medicine, Stanford University
      ClinicalTrials.gov Identifier:
      NCT01144793
      Other Study ID Numbers:
      • HEM0008
      • 98712
      • SU-07102008-1246
      • 12769
      First Posted:
      Jun 16, 2010
      Last Update Posted:
      Dec 28, 2016
      Last Verified:
      Dec 1, 2016
      Individual Participant Data (IPD) Sharing Statement:
      No
      Plan to Share IPD:
      No
      Additional relevant MeSH terms:
      Leukemia
      Leukemia, Myeloid
      Leukemia, Lymphoid
      Febrile Neutropenia

      Study Results

      No Results Posted as of Dec 28, 2016