Multiple Organ FailureNCT03059524
Dynamic Monitoring of Circulating microRNA Changes in Patients With or Without Multiple Organ Failure
An observational study of Multiple Organ Failure, run by University of Electronic Science and Technology of China at 1 site in China.
Trial summary
The objectives are to: 1. validate a panel of tissue-specific miRNAs that are differentially expressed in the plasma of patients with and without multiple organ failure. 2. investigate the dysregulation of circulating miRNA panel and their prognostic and predictive values in clinical outcomes in identifying patients… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Organ Failure
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Dec 2018
- 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: This research project will recruit a cohort of prospective observational cancer patients in ICU. Admitted patients will be followed-up in the inpatient units in concordance with ICU protocols. Upon discharged, patients will be followed-up in every 28 days for any disease recurrence and clinical outcomes.
Who may be able to join
- Adults 18 years and above
- Has condition related to ICU enrollment cause
- Adults 18 years and above
Who cannot join
- Age below 18 years
- Known pregnancy
- Treating physician deems aggressive care unsuitable
- Unable to provide informed consent or comply with study requirements
- Underlying chronic inflammatory condition (e.g. inflammatory bowel disease)
- Underlying autoimmune disease (e.g. rheumatoid arthritis, systemic lupus erythematosus)
- Pre-existent liver disorder
- User of any prescript medicine or over the counter drugs in prior 7 days.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
University of Electronic Science and Technology of China
Chengdu, Sichuan, 610054
Huang Jian, Ph.D, + 86-28-83202351, hj@uestc.edu.cn
About this study
The objectives are to:
- validate a panel of tissue-specific miRNAs that are differentially expressed in the plasma of patients with and without multiple organ failure.
- investigate the dysregulation of circulating miRNA panel and their prognostic and predictive values in clinical outcomes in identifying patients at high risk for mortality and multiple organ failure.
This trial involves peripheral blood sampling from subjects at their earliest presentation and remaining stays in the hospitalization in the emergency department. The investigators will develop panels of miRNAs that are specific indicator of early onset of major organ failures, and correlate clinical outcomes with these miRNAs.
Read the detailed description
The ICU patients with multiple organ failure in sponsor's institutes will be enrolled in this observational cohort of investigation. Whole blood samples will be separated immediately into plasma for storage. The participants will have their 2nd and 3rd samples obtained at 24-48 hours and 48-72 hours respectively. The schedule of most of sampling schedule is designed in concordance with the ICU routines to avoid extra burdens on patients. The plasma samples will be used as prognostic markers in prognostic and predictive values in identifying patients at high risk for mortality and multiple organ failure. Patients who are discharged will be tracked for any clinical recurrence of the diseases every 28 days to assess the diagnostic accuracy of the miRNA biomarkers that are measured.
The 2nd objective will be assessed by measuring the concentration of miRNAs in normal patients without multiple organ failure.
The circulating miRNAs will be detected directly from 1 - 5 ul of plasma samples with the miRFLP assay. This capillary electrophoresis-based miRNA quantification method detects multiple miRNAs in absolute copy number in smaller sample signature with negligible batch to batch variation, thus providing a standard miRNA detection method.
- Conditions
- Multiple Organ Failure
- Keywords
- microRNA
- Medical subject headings
- Multiple Organ Failure
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 |
|---|---|---|
| patients with multiple organ failure | Not described | |
| patients without multiple organ failure | Not described | |
| normal subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The concentration of circulating miRNA expression quantitated in absolute copy numbers in ICU patients with or without multiple organ failures.
The circulating miRNA concentration is to be measured in patient plasma samples with or without multiple organ failures. The comparison of miRNA expression will be performed to investigate the potential prognostic value of the miRNA panel on survival rates at the onset of multiple organ failures.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startJan 2017
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Organ FailureStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Electronic Science and Technology of China
- Sponsor type
- University, hospital or other
- Collaborators
- Chengdu Nuoen Biotechnologies, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03059524
- Sponsor's protocol ID
- Uestc501
- Status last verified
- Feb 2017
- First submitted
- 9 Jan 2017
- Last updated
- 23 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Monitoring of Circulating microRNA Changes in Patients With or Without Multiple Organ Failure
- ClinicalTrials.gov ID
- NCT03059524
- Acronym / sponsor ID
- Uestc501
- Conditions
- Multiple Organ Failure
- Keywords
- microRNA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Electronic Science and Technology of ChinaUniversity, hospital or other
- Collaborators
- Chengdu Nuoen Biotechnologies, Inc.
- Study start
- Jan 2017
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 23 Feb 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.
The objectives are to:
- validate a panel of tissue-specific miRNAs that are differentially expressed in the plasma of patients with and without multiple organ failure.
- investigate the dysregulation of circulating miRNA panel and their prognostic and predictive values in clinical outcomes in identifying patients at high risk for mortality and multiple organ failure.
This trial involves peripheral blood sampling from subjects at their earliest presentation and remaining stays in the hospitalization in the emergency department. The investigators will develop panels of miRNAs that are specific indicator of early onset of major organ failures, and correlate clinical outcomes with these miRNAs.
Detailed description
The ICU patients with multiple organ failure in sponsor's institutes will be enrolled in this observational cohort of investigation. Whole blood samples will be separated immediately into plasma for storage. The participants will have their 2nd and 3rd samples obtained at 24-48 hours and 48-72 hours respectively. The schedule of most of sampling schedule is designed in concordance with the ICU routines to avoid extra burdens on patients. The plasma samples will be used as prognostic markers in prognostic and predictive values in identifying patients at high risk for mortality and multiple organ failure. Patients who are discharged will be tracked for any clinical recurrence of the diseases every 28 days to assess the diagnostic accuracy of the miRNA biomarkers that are measured.
The 2nd objective will be assessed by measuring the concentration of miRNAs in normal patients without multiple organ failure.
The circulating miRNAs will be detected directly from 1 - 5 ul of plasma samples with the miRFLP assay. This capillary electrophoresis-based miRNA quantification method detects multiple miRNAs in absolute copy number in smaller sample signature with negligible batch to batch variation, thus providing a standard miRNA detection method.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients with multiple organ failure | – | – |
| patients without multiple organ failure | – | – |
| normal subjects | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This research project will recruit a cohort of prospective observational cancer patients in ICU. Admitted patients will be followed-up in the inpatient units in concordance with ICU protocols. Upon discharged, patients will be followed-up in every 28 days for any disease recurrence and clinical outcomes.
Key inclusion criteria (3 listed)
- Adults 18 years and above
- Has condition related to ICU enrollment cause
- Adults 18 years and above
Key exclusion criteria (8 listed)
- Age below 18 years
- Known pregnancy
- Treating physician deems aggressive care unsuitable
- Unable to provide informed consent or comply with study requirements
- Underlying chronic inflammatory condition (e.g. inflammatory bowel disease)
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
The concentration of circulating miRNA expression quantitated in absolute copy numbers in ICU patients with or without multiple organ failures.
Time frame: 3 years
The circulating miRNA concentration is to be measured in patient plasma samples with or without multiple organ failures. The comparison of miRNA expression will be performed to investigate the potential prognostic value of the miRNA panel on survival rates at the onset of multiple organ failures.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
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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.
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 Multiple Organ Failure, run by University of Electronic Science and Technology of China 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 3 inclusion and 8 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 23 Feb 2017. 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 Liu Zhenjun (+ 86-28-85420949, 84696484@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The concentration of circulating miRNA expression quantitated in absolute copy numbers in ICU patients with or without multiple organ failures. (time frame: 3 years). 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 23 Feb 2017.