T Lymphocyte DisorderNCT02756559
MiRNAs Evaluating Lymphocyte Proliferation and Apoptosis as Well as Prognosis of Sepsis
An observational study of T Lymphocyte Disorder, run by Lixin Xie at 1 site in China.
Trial summary
Sepsis is a systemic inflammatory reaction caused by infection, trauma, etc. In the process of sepsis, the apoptosis of lymphocyte serves as a vital factor of immune dysfunction. Micro-RNAs (miRNAs) are endogenous small non-coding RNA molecules. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- T Lymphocyte Disorder
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jan 2014to Dec 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Blood samples were collected from the Chinese People's Liberation Army General Hospital. The investigators collected samples in emergency intensive care unit (EICU), surgical intensive care unit (SICU) and respiratory intensive care unit (RICU),within 24 hours admitted into ICU.
Who may be able to join
- Diagnosis of Sepsis
- Agree with this study
Who cannot join
- Age <18 years
- Died within 24 hours
- Combined with HIV infection
- Agranulocytosis
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, 100853
Dan Liu, Principal Investigator, +86 13920701949, liudan_nkdx@163.com
Lixin Xie, Clinical Professor
About this study
Sepsis is a systemic inflammatory reaction caused by infection, trauma, etc. In the process of sepsis, the apoptosis of lymphocyte serves as a vital factor of immune dysfunction. Micro-RNAs (miRNAs) are endogenous small non-coding RNA molecules. Our previous studies have showed the diagnostic and prognostic value of a series circulant miRNAs in human serum in sepsis. The present research further study the regulatory mechanism of those miRNAs in lymphocyte in sepsis. Our research is based on the clinical value of miR-223, miR-15a, miR-16. The investigators discuss the potential role of miR-223, miR-15a, miR-16 in regulating the proliferation and apoptosis of lymphocyte in sepsis and aim to find new targets for sepsis treatment.
Read the detailed description
Blood samples were collected from the Chinese People's Liberation Army General Hospital. The investigators collected samples in emergency intensive care unit (EICU), surgical intensive care unit (SICU) and respiratory intensive care unit (RICU) between July 2014 to March 2015. Septic patients were divided into sepsis, severe sepsis and septic shock according to the diagnostic criteria. Peripheral white blood cells were sorted into monocytes, lymphocytes and neutrophils by using flow cytometry (Flow Cytometry, FCM). Jurkat T cell lines were purchased from Chinese Academy of Medical Sciences Institute of basic medical sciences. miRNAs agomirs and antagonists were used to establish miR-223, miR-15a, miR-16 overexpression and knock-out transient transfection cell lines. Western blot was used to detect difference expression of protein expression.
- Conditions
- T Lymphocyte Disorder
- Keywords
- sepsis, microRNAs
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| sepsis, severe sepsis and septic shock | Septic patients were divided into sepsis, severe sepsis and septic shock |
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: 28 days after admitted to ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startJan 2014
- Primary completionJun 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T Lymphocyte DisorderStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lixin Xie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lixin Xie, Chinese PLA General Hospital
- Investigators
- Lixin Xie, Clinical Professor, Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756559
- Sponsor's protocol ID
- S2015-068-01
- Status last verified
- Apr 2016
- First submitted
- 25 Apr 2016
- Last updated
- 2 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MiRNAs Evaluating Lymphocyte Proliferation and Apoptosis as Well as Prognosis of Sepsis
- ClinicalTrials.gov ID
- NCT02756559
- Acronym / sponsor ID
- S2015-068-01
- Conditions
- T Lymphocyte Disorder
- Keywords
- sepsis, microRNAs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Lixin XieUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 29 Apr 2016 (estimated)
- 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.
Sepsis is a systemic inflammatory reaction caused by infection, trauma, etc. In the process of sepsis, the apoptosis of lymphocyte serves as a vital factor of immune dysfunction. Micro-RNAs (miRNAs) are endogenous small non-coding RNA molecules. Our previous studies have showed the diagnostic and prognostic value of a series circulant miRNAs in human serum in sepsis. The present research further study the regulatory mechanism of those miRNAs in lymphocyte in sepsis. Our research is based on the clinical value of miR-223, miR-15a, miR-16. The investigators discuss the potential role of miR-223, miR-15a, miR-16 in regulating the proliferation and apoptosis of lymphocyte in sepsis and aim to find new targets for sepsis treatment.
Detailed description
Blood samples were collected from the Chinese People's Liberation Army General Hospital. The investigators collected samples in emergency intensive care unit (EICU), surgical intensive care unit (SICU) and respiratory intensive care unit (RICU) between July 2014 to March 2015. Septic patients were divided into sepsis, severe sepsis and septic shock according to the diagnostic criteria. Peripheral white blood cells were sorted into monocytes, lymphocytes and neutrophils by using flow cytometry (Flow Cytometry, FCM). Jurkat T cell lines were purchased from Chinese Academy of Medical Sciences Institute of basic medical sciences. miRNAs agomirs and antagonists were used to establish miR-223, miR-15a, miR-16 overexpression and knock-out transient transfection cell lines. Western blot was used to detect difference expression of protein expression.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sepsis, severe sepsis and septic shock | – | –Septic patients were divided into sepsis, severe sepsis and septic shock |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Blood samples were collected from the Chinese People's Liberation Army General Hospital. The investigators collected samples in emergency intensive care unit (EICU), surgical intensive care unit (SICU) and respiratory intensive care unit (RICU),within 24 hours admitted into ICU.
Key inclusion criteria (2 listed)
- Diagnosis of Sepsis
- Agree with this study
Key exclusion criteria (4 listed)
- Age <18 years
- Died within 24 hours
- Combined with HIV infection
- Agranulocytosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
all cause mortality
Time frame: 28 days after admitted to ICU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2016.
- 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.
Lixin Xie, Clinical Professor study chair
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of T Lymphocyte Disorder, run by Lixin Xie at 1 site in China.
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 4 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 2 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Dan Liu, Principal Investigator (+86 13920701949, liudan_nkdx@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (time frame: 28 days after admitted to ICU). 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 2 May 2016; AzTrials last refreshed its copy on 7 Nov 2026.