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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:	7 March 2022
Main ID:	ChiCTR2100048082
Date of registration:	2021-06-30
Prospective Registration:	Yes
Primary sponsor:	The Affiliated Drum Tower Hospital of Nanjing University Medical School
Public title:	Identification of Serum and Exosome Markers in Lupus Nephritis
Scientific title:	Development and Application of an Early Diagnosis Scheme for Lupus Nephritis Based on Serum Noncoding Small RNA
Date of first enrolment:	2021-07-01
Target sample size:	Target condition:100;Difficult condition:100
Recruitment status:	Recruiting
URL:	http://www.chictr.org.cn/showproj.aspx?proj=129225
Study type:	Diagnostic test
Study design:	Sequential
Phase:	0

Countries of recruitment
China

Contacts

Name:	Li Zhiyang
Address:	321 Zhongshan Road, Nanjing, Jiangsu, China
Telephone:	+86 18951703765
Email:	lizhiyangcn@qq.com
Affiliation:	The Affiliated Drum Tower Hospital of Nanjing University Medical School

Name:	Yang Ping
Address:	321 Zhongshan Road, Nanjing, Jiangsu, China
Telephone:	+86 13952071825
Email:	anthyony@126.com
Affiliation:	The Affiliated Drum Tower Hospital of Nanjing University Medical School

Key inclusion & exclusion criteria

Inclusion criteria: 1. Two hundred SLE patients diagnosed by immunology and confirmed by pathology were collected, including 100 patients with nephritis and 100 patients without nephritis. Serum samples were collected before treatment;
2. Healthy control group : 100 healthy subjects matched with age and gender of SLE patients in the same period were selected from the physical examination center of Gulou Hospital.
Exclusion criteria: Tumors and other autoimmune diseases were excluded.

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Gold Standard:The SLE classification standard revised by the American Academy of Rheumatology in 1997 and the SLE classification standard revised by the American Academy of Rheumatology in 2009;Index test:serum and exosome markers;

Primary Outcome(s)

Sensitivity;

Secondary Outcome(s)

Secondary ID(s)

Source(s) of Monetary Support

National Natural Science Foundation of China

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 09/12/2020
Contact:

Results

Results available:
Date Posted:
Date Completed:
URL:

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