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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ChiCTR
Last refreshed on: 10 October 2018
Main ID:  ChiCTR1800018637
Date of registration: 2018-09-30
Prospective Registration: No
Primary sponsor: Affiliated Hospital of North Sichuan Medical College
Public title: Correlation between Human epididymis protein 4 and interstitial lung disease in patients with rheumatoid arthritis
Scientific title: Correlation between Human epididymis protein 4 and interstitial lung disease in patients with rheumatoid arthritis
Date of first enrolment: 2018-09-26
Target sample size: Target condition:150;Difficult condition:100
Recruitment status: Recruiting
URL:  http://www.chictr.org.cn/showproj.aspx?proj=31452
Study type:  Diagnostic test
Study design:  Diagnostic test: case-control  
Phase:  Diagnostic New Technique Clincal Study
Countries of recruitment
China
Contacts
Name: Fan Quming   
Address:  63 Wenhua Road, Nanchong, Sichuan, China 63700
Telephone: +86 13550592716
Email: fanqum@163.com
Affiliation:  Affiliated Hospital of North Sichuan Medical College
Name: Fan Quming   
Address:  63 Wenhua Road, Nanchong, Sichuan, China 637000
Telephone: +86 13550592716
Email: fanqum@163.com
Affiliation:  Affiliated Hospital of North Sichuan Medical College
Key inclusion & exclusion criteria
Inclusion criteria: (1) the diagnosis of RA in line with the 2010 American rheumatism association (ACR) for RA classification criteria;
(2) perfect the relevant inspection, a complete medical records.The cases were divided into 2 groups, group by: referring to the 2000 ATS diagnostic criteria, proposed ILD will chest high-resolution CT findings of nodules, patchy shadow, changes in a funicular, pleural thickening and pulmonary fibrosis patients classified as group with pulmonary interstitial change group.the rest is non-pulmonary parenchymal changes RA group.

Exclusion criteria: (1) with other connective tissue diseases;
(2) in chronic kidney disease;
(3) there are serious pulmonary infection, pulmonary tuberculosis, lung cancer and other lung diseases;
(4) ovarian cancer, endometrial cancer and other gynecological malignant tumors.


Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
rheumatoid arthritis
Intervention(s)
Gold Standard:Clinical outcome, meet the 2010 ACR/EULAR rheumatoid arthritis classification criteria.;Index test:Human epididymis protein 4,anti-cyclic citrullinated peptide, creatinine, rheumatoid factor;
Primary Outcome(s)
Human epididymis protein 4;Imaging indicators of pulmonary fibrosis;creatinine;
Secondary Outcome(s)
anti-cyclic citrullinated peptide;rheumatoid factor;DAS28;
Secondary ID(s)
Source(s) of Monetary Support
Lateral project funding?,national sci-tech support plan
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 29/03/2018
Contact:
Huang Meijie
Results
Results available:
Date Posted:
Date Completed:
URL:
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