Comparative Study of Circulating microRNA Changes in Patients With Liver Injury and Healthy Subjects

NCT03000621 | Unknown

• 1 other identifier: Uestc500
• 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 liver injuries
2. 2.investigate the physiological range of the circulating miRNA panel in Healthy Subjects and under stress
3. 3.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 acute liver failure.

Conditions

Drug-Induced Liver Injury; Liver Failure

Keywords

MicroRNA; miR-122; Diagnosis; Prognosis

Outcome Measures

Primary Outcomes (1)

• The concentration of circulating miRNA expression quantitated in absolute copy numbers in ICU patients and their correlation with liver failure

  The concentration of circulating miRNAs in absolute quantification in comparison to the severity of liver injury (control vs. liver injury vs. acute liver injury). To investigate the potential prognosis of liver failure by the expression difference of the miRNA panel at the onset of liver injury. Sensitivity, specificity and the potential scopes of selected miRNA in the miRNA panel to distinguish different severity of liver injury and against standard clinical parameters, serum amonotransferases (ALT, AST), total bilirubin measurement.

  Three years

Secondary Outcomes (1)

• The possible physiological range of selected miRNAs in healthy subjects and the performance metrics of the miRNA detection methodology

  Three years

Study Arms (2)

Patients with liver injury

Healthy subjects

Eligibility Criteria

• Age: 18 Years - 75 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 after surgery or chemotherapy. 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. Healthy controls will also be recruited to demonstrate the physiological level of different circulating miRNAs.

You may qualify if:

• Adults 18 years and above

You may not qualify if:

• 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 prescribed medicine or over the counter drugs in prior 7 days.
• Adults 18 years and above Has condition related to ICU enrollment cause
• Age below 18 years Known pregnancy Treating physician deems aggressive care unsuitable Unable to provide informed consent or comply with study requirements

Sponsors & Collaborators

• University of Electronic Science and Technology of China: lead
• Chengdu Nuoen Biotechnologies, Inc.: collaborator
• Sichuan Cancer Hospital and Research Institute: 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

Chemical and Drug Induced Liver Injury; Liver Failure; Disease

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Poisoning; Hepatic Insufficiency; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Huang Jian, PhD

  University of Electronic Science and Technology of China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kang Juanjuan

CONTACT

+ 86-28-83202351; kjj@immunet.cn

Study Design

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

Study Record Dates

• First Submitted: December 17, 2016
• First Posted: December 22, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: May 30, 2017

Record last verified: 2016-10

Locations

CN (1)