The Role of Circulating Soluble CD74 in Acute Lung Injury

Inflammation Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02201446
• Other study ID #: 20131224
• Status: Recruiting
• Phase: N/A
• First received: July 24, 2014
• Last updated: July 25, 2014
• Start date: March 2014

Study information

• Verified date: July 2014
• Source: Changhai Hospital
• Contact: Zhaofan Xia, MD PhD
• Phone: 86 21 31161821
• Email: xiazhaofan[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial Summary

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 our hypothesis that soluble CD74 might be a potential novel ALI/ARDS biomarker.

Description:

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.

CD74 (also known as a MHC class II invariant chain) is a type II transmembrane protein, recently found to be the high-affinity receptor of macrophage migration inhibitory factor (MIF). MIF promotes neutrophil accumulation in alveolar space via binding to CD74 expressed on the cell surface. Our previous study， consistent with others, has shown that MIF was highly expressed in acute lung injury (ALI). In addition, we also detected highly CD74 expression in lipopolysaccharide (LPS)-induced ALI mouse model. Recently, a circulating form of CD74 was discovered in autoimmune liver disease. Similarly, we investigated the existence of soluble form of CD74 in serum and bronchoalveolar lavage fluid (BALF) in ALI mouse model and burn or trauma related ALI patients. Based on these finds, we postulated that soluble CD74 might participate in regulating lung inflammation and be a potential novel ALI/ARDS biomarker.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Biomarker
• Inflammation
• Lung
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Locations

Country	Name	City	State
China	Department of Burn and Trauma Sugery, Changhai Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to death		up to 28 days	No
Secondary	Time to discharge	participants will be followed for the duration of hospital stay, an expected average of 4 weeks.	an expected average of 4 weeks	No