Optimization of Time-of-Flight Mass Cytometry (CyTOF) Analysis for Evaluation of Immune Changes Following Surgery

Surgical Trauma Clinical Trial

Official title:

Detection of Immune Changes as a Result of Surgical Trauma in Human Back Surgery Subjects: Optimization of CyTOF Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01882569
• Other study ID #: 24014
• Status: Completed
• Phase: N/A
• First received: June 18, 2013
• Last updated: May 2, 2016
• Start date: May 2012
• Est. completion date: September 2014

Study information

• Verified date: May 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: USA: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Surgical trauma triggers a massive inflammatory response. Over time, both the innate and adaptive branches of the immune system are affected by surgical trauma. The purpose of this study is to use a single cell flow cytometry approach to characterize the cellular and molecular mechanisms involved in the inflammatory response to surgical trauma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: September 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Ages 18 - 90

2. Men and women

3. Undergo back surgery

Exclusion Criteria:

1. Any systemic disease that might compromise the immune system (e.g. lupus)

2. Current diagnosis of cancer

3. Any condition that, in the opinion of the investigator, might compromise the integrity of the study or safety of the participant.

4. Unwilling to sign informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Surgical Trauma

Locations

Country	Name	City	State
United States	Stanford University Hospital	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Martin Angst

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical (cell frequencies) and functional (phosphorylation of signaling proteins and transcription factors) changes of all circulating immune cells	This is an exploratory study.	Immediately before to surgery, 1 hour after surgery, 24 hours after surgery, and day of hospital discharge	No