- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01882569
Optimization of Time-of-Flight Mass Cytometry (CyTOF) Analysis for Evaluation of Immune Changes Following Surgery
May 2, 2016 updated by: Martin Angst
Detection of Immune Changes as a Result of Surgical Trauma in Human Back Surgery Subjects: Optimization of CyTOF Analysis
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
5
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Generally healthy patients undergoing back surgery
Description
Inclusion Criteria:
- Ages 18 - 90
- Men and women
- Undergo back surgery
Exclusion Criteria:
- Any systemic disease that might compromise the immune system (e.g. lupus)
- Current diagnosis of cancer
- Any condition that, in the opinion of the investigator, might compromise the integrity of the study or safety of the participant.
- Unwilling to sign informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Back surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numerical (cell frequencies) and functional (phosphorylation of signaling proteins and transcription factors) changes of all circulating immune cells
Time Frame: Immediately before to surgery, 1 hour after surgery, 24 hours after surgery, and day of hospital discharge
|
This is an exploratory study.
|
Immediately before to surgery, 1 hour after surgery, 24 hours after surgery, and day of hospital discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Martin S Angst, MD, Stanford University SOM
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
September 1, 2014
Study Registration Dates
First Submitted
June 18, 2013
First Submitted That Met QC Criteria
June 18, 2013
First Posted (Estimate)
June 20, 2013
Study Record Updates
Last Update Posted (Estimate)
May 4, 2016
Last Update Submitted That Met QC Criteria
May 2, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Surgical Trauma
-
Martin AngstCompletedSurgical TraumaUnited States
-
ConvaTec Inc.WithdrawnSurgical Wound, Recent | Trauma-related Wound | Dehiscence Wound | Surgical Wound LeakUnited States
-
[Redacted]United States Department of Defense; The University of Texas Health Science... and other collaboratorsWithheldSurgical Wound | Surgical Incision | Laceration | Trauma-related WoundUnited States
-
3MCompletedSurgical Wound, Recent | Trauma-related WoundUnited States
-
MetroHealth Medical CenterCompletedMedical Record Documenation | Surgical and Trauma Intensive Care Unit BillingUnited States
-
University of Maryland, BaltimoreRecruitingLower Extremity Fracture | Orthopaedic Trauma | Surgical Fracture Repair | Orthogeriatric FracturesUnited States
-
The Metis FoundationUnited States Department of Defense; The University of Texas Medical Branch... and other collaboratorsNot yet recruitingBurns | Surgical Wound | Trauma Injury
-
ConvaTec Inc.CompletedSurgical Wound | Trauma-related WoundUnited States
-
Silvia M. Pinango L.Merck Sharp & Dohme LLCCompletedSURGICAL SITE INFECTION
-
Florida Orthopaedic InstituteUnknownBone Fractures Multiple