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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Stanford University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Theranos, Inc.
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT01144793
First received: June 14, 2010
Last updated: June 15, 2010
Last verified: June 2010
History of Changes
  Purpose

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
Leukemia, Lymphocytic
Leukemia, Myeloid

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

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

Further study details as provided by Stanford University:

Biospecimen Retention:   Samples Without DNA

blood


Estimated Enrollment: 15
Study Start Date: April 2008
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Acute or Chronic Leukemias

Criteria

Inclusion Criteria:- Age >= 18

  • Pre-admission (ATU, ITA) or inpatient status
  • 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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01144793

Locations
United States, California
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
  More Information

No publications provided

Responsible Party: Jason Robert Gotlib, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT01144793     History of Changes
Other Study ID Numbers: SU-07102008-1246, 98712, HEM0008
Study First Received: June 14, 2010
Last Updated: June 15, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 21, 2013