Dynamic Monitoring of Circulating microRNA Changes in Patients With or Without Multiple Organ Failure

NCT03059524 | Unknown

• 1 other identifier: Uestc501
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives are to:

1. 1.validate a panel of tissue-specific miRNAs that are differentially expressed in the plasma of patients with and without multiple organ failure.
2. 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.

Conditions

Multiple Organ Failure

Keywords

microRNA

Outcome Measures

Primary Outcomes (1)

• 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.

  3 years

Study Arms (3)

patients with multiple organ failure

patients without multiple organ failure

normal subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Age below 18 years
• Known pregnancy
• Treating physician deems aggressive care unsuitable
• Unable to provide informed consent or comply with study requirements
• Adults 18 years and above
• 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.

Sponsors & Collaborators

• University of Electronic Science and Technology of China: lead
• Chengdu Nuoen Biotechnologies, Inc.: collaborator

Study Sites (1)

University of Electronic Science and Technology of China

Chengdu, Sichuan, 610054, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood extraction from subjects subsequently separated to plasma.

MeSH Terms

Conditions

Multiple Organ Failure

Condition Hierarchy (Ancestors)

Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Liu Zhenjun

CONTACT

+ 86-28-85420949; 84696484@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: February 23, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

CN (1)