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

NCT01144793 | Completed

• 4 other identifiers: HEM000898712SU-07102008-124612769
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia, Lymphocytic; Leukemia, Myeloid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Acute or Chronic Leukemias

You may qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• Theranos, Inc.: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• Chan SM, Chadwick J, Young DL, Holmes E, Gotlib J. Intensive serial biomarker profiling for the prediction of neutropenic Fever in patients with hematologic malignancies undergoing chemotherapy: a pilot study. Hematol Rep. 2014 Jun 23;6(2):5466. doi: 10.4081/hr.2014.5466. eCollection 2014 Apr 22.

  PMID: 25013718 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood

MeSH Terms

Conditions

Leukemia, Lymphoid; Leukemia, Myeloid

Condition Hierarchy (Ancestors)

Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jason Robert Gotlib

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: June 14, 2010
• First Posted: June 16, 2010
• Study Start: April 1, 2008
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: December 28, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)