SepsisNCT03379896
Study on Antigen-presenting Function of Gamma Delta T Cells in Sepsis and Its Molecular Mechanisms
An observational study of Sepsis and Antigen-presenting Function, run by West China Hospital.
Trial summary
Study on antigen-presenting function of gamma delta T cells in sepsis and its molecular mechanisms Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Antigen-presenting Function, γδ T Cells
- What is being tested?
- Collect peripheral blood sample
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 4 Jan 2018to 30 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- ≥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.
Who cannot join
- autoimmune disease,
- history of transplantation,
- acute tuberculosis,
- chronic hepatitis B or C infection,
- HIV infection,
- active malignancy, and
- long-term use of cortical steroids.
Trial locations and contacts
No sites are listed yet.
About this study
Study on antigen-presenting function of gamma delta T cells in sepsis and its molecular mechanisms
Read the 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.
- Conditions
- Sepsis, Antigen-presenting Function, γδ T Cells
- Being tested
- Collect peripheral blood sample
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collect peripheral blood sampleOther
Collect 20 ml heparinized blood from patients and controls strictly abiding by the principle of aseptic manipulation after informed consent.
| Study group | Role | What they receive |
|---|---|---|
| Sepsis | Patient diagnosed with sepsis according to the new sepsis definition (infection+SOFA≥2). Receives: Other: Collect peripheral blood sample | |
| Control | Age-matched healthy control Receives: Other: Collect peripheral blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day clinical outcome
death
Measured: 28-day after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start4 Jan 2018 (estimated)
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kang Yan, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379896
- Sponsor's protocol ID
- 81701880
- Status last verified
- Dec 2017
- First submitted
- 16 Dec 2017
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Antigen-presenting Function of Gamma Delta T Cells in Sepsis and Its Molecular Mechanisms
- ClinicalTrials.gov ID
- NCT03379896
- Acronym / sponsor ID
- 81701880
- Conditions
- Sepsis, Antigen-presenting Function, γδ T Cells
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 4 Jan 2018 (estimated)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 20 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study on antigen-presenting function of gamma delta T cells in sepsis and its molecular mechanisms
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sepsis | – | Other: Collect peripheral blood samplePatient diagnosed with sepsis according to the new sepsis definition (infection+SOFA≥2). |
| Control | – | Other: Collect peripheral blood sampleAge-matched healthy control |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- ≥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.
Key exclusion criteria (7 listed)
- autoimmune disease,
- history of transplantation,
- acute tuberculosis,
- chronic hepatitis B or C infection,
- HIV infection,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collect peripheral blood sampleCollect 20 ml heparinized blood from patients and controls strictly abiding by the principle of aseptic manipulation after informed consent. | Other | Control, Sepsis |
Primary outcome
28-day clinical outcome
Time frame: 28-day after ICU admission
death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Antigen-presenting Function, run by West China Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xuelian Liao, MD (8613541023033, xuelianliao@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day clinical outcome (time frame: 28-day after ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2017.