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OpenTrials
Completed

NCT Number: NCT01144793

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Theranos, Inc.

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 16, 2010
Registry last updated
Dec 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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