The Role of Circulating CircRNAs and MicroRNAs in Acute Lung Injury

NCT ID: NCT03766204

Last Updated: 2018-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2024-12-31

Brief Summary

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Efforts to identify circulating factors that predict severity of acute lung injury/acute respiratory distress syndrome(ALI/ARDS)patients is unrevealing. The primary purpose of this study is to verify circRNAs and microRNAs might be potential novel ALI/ARDS biomarkers and could play roles in pathogenesis of ALI/ARDS.

Detailed Description

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Acute lung injury (ALI) or acute respiratory distress syndrome (ARDS) is a devastating cause of morbidity and mortality characterized by alveolar epithelial and endothelial injury. Despite recent advances in pathogenetic mechanisms and therapy strategies of ALI, efforts to identify circulating factors that predict severity of ALI/ARDS patients have been unrevealing.

Circular RNAs (circRNAs) are a novel class of endogenous non-coding RNA with a covalently continuous closed-loop structure. Compared with traditional linear RNAs, circRNAs are more stable and resistant to RNase R due to the absence of 5' caps and 3' tails, which show clear advantages in acting as novel molecular biomarkers for many diseases. In addition, many studies have reported that circRNAs can bind to microRNAs (miRNAs), acting as "miRNA sponges" which are named competitive endogenous RNAs (ceRNAs), and can regulate gene expression at the transcriptional or post-transcriptional level. Evidence indicates that circRNAs play important roles in cancers and other diseases such as tuberculosis and intervertebral disc degeneration. As no published research has studied the expression and role of circRNAs in the pathology and pathogenesis of ALI/ARDS, the investigators aimed to validate the aberrant expression of circRNAs in ALI/ARDS and explore the potential pathological mechanism in which circRNAs are involved.

Conditions

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Acute Lung Injury Acute Respiratory Distress Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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ARDS patients

137 patients were enrolled consecutively over a two-year time period (2017-2018) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 18 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.

No interventions assigned to this group

Healthy volunteers

Forty healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of ALI/ARDS
* Informed consent was obtained from either the subjects themselves or from designated surrogates before enrollment in the study.

Exclusion Criteria

* Patients who have chronic lung disease before enrollment.
* Patients who have severe organ dysfunction, autoimmune diseases and tumor.
* Women who are pregnant or breast-feeding.
* Patients who, in the opinion of the Investigator, have any other medical condition which renders the patient unable to complete the study or which would interfere with optimal participation in the study or produce significant risk to the patient.
* Patients participating in or planning to enroll in another clinical trial during the time of the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhaofan Xia

President

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhao-fan Xia, MD;PHD

Role: STUDY_DIRECTOR

Department of Burn Sugery, Changhai Hospital

Locations

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Department of Burn and Trauma Sugery, Changhai Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhao-fan Xia, MD;PHD

Role: CONTACT

86-21-31161821

Yong Jiang, MD

Role: CONTACT

86-15721570244

Facility Contacts

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Zhao-fan Xia, MD;PHD

Role: primary

+862131161821

Yong Jiang, MD

Role: backup

86-15721570244

Other Identifiers

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20181204

Identifier Type: -

Identifier Source: org_study_id

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