Clinical trial NCT03059524: Dynamic Monitoring of Circulating microRNA Changes in Patients With or Without Multiple Organ Failure
Official title: Dynamic Monitoring of Circulating microRNA Changes in Patients With or Without Multiple Organ Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Organ Failure
Keywords: microRNA
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
Collaborators: name: Chengdu Nuoen Biotechnologies, Inc.
First posted: 2017-02-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.

Eligibility criteria: Inclusion Criteria for subjects:

* Adults 18 years and above
* Has condition related to ICU enrollment cause

Exclusion Criteria for subjects:

* Age below 18 years
* Known pregnancy
* Treating physician deems aggressive care unsuitable
* Unable to provide informed consent or comply with study requirements

Inclusion criteria for normal controls:

• Adults 18 years and above

Exclusion criteria for normal controls:

* 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.

Primary outcomes:
measure: The concentration of circulating miRNA expression quantitated in absolute copy numbers in ICU patients with or without multiple organ failures.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: University of Electronic Science and Technology of China
state: Sichuan
Study officials:
References: