- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03379896
Study on Antigen-presenting Function of Gamma Delta T Cells in Sepsis and Its Molecular Mechanisms
December 20, 2017 updated by: Kang Yan, West China Hospital
Study on antigen-presenting function of gamma delta T cells in sepsis and its molecular mechanisms
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
The latest definition of sepsis highlights the role of dysregulated host response to infection in organ dysfunction aggravation.
Maintenance of immune homeostasis of septic patients through immunotherapy is the key breakthrough to improve success rate.
Antigen-presenting cell (APC) is the bridge that connects the innate and adaptive immunity.
Decrease of count and function of APC has been shown to be associated with worsened clinical outcomes in patients with sepsis.
Gamma-delta T cells (γδ T cells) are the newly identified population of T lymphocytes.
Recent studies have found that γδ T cells possess unique and powerful antigen-presenting function, making them the hot topic in infection and cancer research.
Based on the results, the investigator plan to evaluate the antigen-presenting function changes of γδ T cells in septic status by analyzing the antigen-presenting related molecules on γδ T cells, antigen protein uptake ability, and their function on the proliferation and activation of CD8+ T lymphocytes.
Furthermore, the investigator will explore the mechanism and signal pathways for the APC function changes of γδ T cells.
Findings from this research could help explain the mechanism of sepsis induced immune dysfunction, enrich our understanding of the important role of γδ T cells, and build a good foundation for immunotherapy in sepsis.
Study Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients with sepsis from department of Critical Care Medicine of West China Hospital are included if they meet the study criteria on ICU admission.
Healthy control subjects are adult volunteers from our hospital staff and their family members with no significant acute or chronic illnesses.
Description
Inclusion Criteria:
- ≥18 year old;
- a known or suspected infection based on clinical data at the time of admission and sepsis-induced dysfunction of at least one organ.
Exclusion Criteria:
- autoimmune disease,
- history of transplantation,
- acute tuberculosis,
- chronic hepatitis B or C infection,
- HIV infection,
- active malignancy, and
- long-term use of cortical steroids.
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 |
Intervention / Treatment |
---|---|
Sepsis
Patient diagnosed with sepsis according to the new sepsis definition (infection+SOFA≥2).
|
Collect 20 ml heparinized blood from patients and controls strictly abiding by the principle of aseptic manipulation after informed consent.
|
Control
Age-matched healthy control
|
Collect 20 ml heparinized blood from patients and controls strictly abiding by the principle of aseptic manipulation after informed consent.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
28-day clinical outcome
Time Frame: 28-day after ICU admission
|
death
|
28-day after ICU admission
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Anticipated)
January 4, 2018
Primary Completion (Anticipated)
June 30, 2020
Study Completion (Anticipated)
December 30, 2020
Study Registration Dates
First Submitted
December 16, 2017
First Submitted That Met QC Criteria
December 19, 2017
First Posted (Actual)
December 20, 2017
Study Record Updates
Last Update Posted (Actual)
December 22, 2017
Last Update Submitted That Met QC Criteria
December 20, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 81701880
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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