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Report for Clinical Trial NCT03236272

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Establishment of a Biomarkers-based Early Warning System of Acute Respiratory Distress Syndrome (ARDS)

The aim of the investigators 'study is to investigate the relationship between the biomarkers (e.g. protein markers, genetic polymorphisms and epigenetic markers) and the onset of ARDS. In this study, the participants were divided into case group (with ARDS) and control group (without ARDS), based on a nested case-control study method. During the diagnosis and treatment, the clinical data of subjects are collected at the given time point. And the clinical data are extracted from plasma, blood and bronchoalveolar lavage fluid of participants. These data will be analyzed based on statistical methods. In the end ,the investigators can build a multi index early warning model based on the biomarkers,which is meaningful for the early diagnosis of the patient with high-risk for ARDS and provide evidence for the early treatment.

NCT03236272 Respiratory Distress Syndrome, Adult
MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome


Primary Outcomes

Description: The protein biomarkers include surfactant protein(SP-D),Clara Cell Protein 16(CC-16),Angiopoietin-2(Ang-2),von Willebrand factor(vWF),Lipopolysaccharide-Binding Protein(LBP) and plasminogen activator inhibitor-1(PAI-1).The subjects will be observed for the content and expression changes of the items mentioned above at day0,1,2,3,4,7. Among participants, for case group patients ,the observation time point,day14 will be added.

Measure: the change of protein biomarkers expression

Time: Day 0,Day 1,Day 2,Day 3,Day 4,Day 7 and Day 14 post-enrollment.

Description: The subjects will be observed for the content and expression changes of the miR-126 at day0,1,2,3,4,7. Among participants, for case group patients ,the observation time point,day14 will be added.

Measure: the change of microRNA-126(miR-126) expression

Time: Day 0,Day 1,Day 2,Day 3,Day 4,Day 7 and Day 14 post-enrollment.

Description: The subjects will be observed for the content and expression changes of the miR-146a at day0,1,2,3,4,7. Among participants, for case group patients ,the observation time point,day14 will be added.

Measure: the change of microRNA-146a(miR-146a) expression

Time: Day 0,Day 1,Day 2,Day 3,Day 4,Day 7 and Day 14 post-enrollment.

Description: Detecting the OCLN gene methylation is based on microarray methylation pattern analysis.The subjects will be detected OCLN gene methylation at day0,1,2,3,4,7. Among participants, for case group patients ,the observation time point day14 will be added.

Measure: Detection of methylation of occludin (OCLN) gene

Time: Day 0,Day 1,Day 2,Day 3,Day 4,Day 7 and Day 14 post-enrollment.

Description: Detecting the genetic polymorphisms,it include mannose binding lectin-2 gene (The Single Nucleotide Polymorphism database (dbSNP) identification number (ID): rs1800450) and lipopolysaccharide-binding peptide (LBP) gene(The Single Nucleotide Polymorphism database (dbSNP) ID: rs2232618)

Measure: Analysis of gene polymorphism

Time: Day 0

Time Perspective: Prospective

Case-Control


There are 2 SNPs

SNPs


1 rs1800450

Detecting the genetic polymorphisms,it include mannose binding lectin-2 gene (The Single Nucleotide Polymorphism database (dbSNP) identification number (ID): rs1800450) and lipopolysaccharide-binding peptide (LBP) gene(The Single Nucleotide Polymorphism database (dbSNP) ID: rs2232618).


2 rs2232618

Detecting the genetic polymorphisms,it include mannose binding lectin-2 gene (The Single Nucleotide Polymorphism database (dbSNP) identification number (ID): rs1800450) and lipopolysaccharide-binding peptide (LBP) gene(The Single Nucleotide Polymorphism database (dbSNP) ID: rs2232618).



HPO Nodes