This trial has been completed.

Conditions leukemia, lymphocytic, leukemia, myeloid
Sponsor Stanford University
Collaborator Theranos, Inc.
Start date April 2008
End date June 2008
Trial size 17 participants
Trial identifier NCT01144793, 12769, 98712, HEM0008, SU-07102008-1246


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

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
Principal investigator Jason Robert Gotlib
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Stanford University.