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

This study has been completed.
Sponsor:
Collaborator:
Theranos, Inc.
Information provided by (Responsible Party):
Jason Robert Gotlib, Stanford University
ClinicalTrials.gov Identifier:
NCT01144793
First received: June 14, 2010
Last updated: December 23, 2016
Last verified: December 2016
  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:


Further study details as provided by Jason Robert Gotlib, Stanford University:

Biospecimen Retention:   Samples Without DNA
blood

Enrollment: 17
Study Start Date: April 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
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.
  Eligibility

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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: Jason Robert Gotlib, Professor of Medicine, Stanford University
ClinicalTrials.gov 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 )
Study First Received: June 14, 2010
Last Updated: December 23, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on July 25, 2017