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Evaluation of Immune Signaling Networks in Healthy Human Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01882582
Recruitment Status : Completed
First Posted : June 20, 2013
Last Update Posted : May 4, 2016
Sponsor:
Information provided by (Responsible Party):
Martin Angst, Stanford University

Tracking Information
First Submitted Date June 18, 2013
First Posted Date June 20, 2013
Last Update Posted Date May 4, 2016
Study Start Date August 2012
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 18, 2013)
Numerical and functional changes of circulating immune cells over time in healthy individuals [ Time Frame: Day 1, Day 2, Day 7, Day 28 ]
This is an exploratory study. Numerical and functional (phosphorylation of signaling molecules and transcription factors) behavior of all circulating immune cells will be captured. Blood specimens collected at referenced time points will be analyzed with mass cytometry.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Immune Signaling Networks in Healthy Human Volunteers
Official Title Evaluation of Immune Signaling Networks in Healthy Human Volunteers
Brief Summary The purpose of this study is to better understand whether and to what extent the activity of immune cells in blood varies over time under normal conditions as assessed in healthy subjects. Results of this study will provide the foundation for helping us evaluate changes in immune cell activities in response to surgery and drugs used in anesthesia. The overall purpose of our research is to understand immune health in the context of anesthesia and surgery.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Study population consists of a community sample.
Condition Normal Immune Cell Function
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 2, 2016)
25
Original Estimated Enrollment
 (submitted: June 18, 2013)
20
Actual Study Completion Date July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Age 18-50
  2. Good general health

Exclusion Criteria:

  1. Recent cold or flu
  2. Chronic use of medications affecting the immune system
  3. Chronic illness
  4. Smoking habit
  5. History of drug abuse
  6. Current recreational drug use
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01882582
Other Study ID Numbers 25292
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Martin Angst, Stanford University
Study Sponsor Martin Angst
Collaborators Not Provided
Investigators
Principal Investigator: Martin S Angst, MD Stanford University SOM
PRS Account Stanford University
Verification Date May 2016