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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: 12 August 2024
Main ID:  ChiCTR2100050481
Date of registration: 2021-08-27
Prospective Registration: Yes
Primary sponsor: Shenzhen Second People's Hospital
Public title: Clinical study of liquid biopsy in membranous nephropathy based on urine exosomal proteome detection
Scientific title: Clinical study of liquid biopsy in membranous nephropathy based on urine exosomal proteome detection
Date of first enrolment: 2021-09-01
Target sample size: Target condition:100;Difficult condition:200
Recruitment status: Recruiting
URL:  https://www.chictr.org.cn/showproj.html?proj=132711
Study type:  Diagnostic test
Study design:  Sequential  
Phase:  N/A
Countries of recruitment
China
Contacts
Name: Cai Yanling   
Address:  3002 Sun'gang Road West, Futian District, Shenzhen, Guangdong
Telephone: +86 13530802052
Email: caiyanling@secretech.com
Affiliation:  Shenzhen Second People's Hospital
Name: Cai Yanling   
Address:  3002 Sun'gang Road West, Futian District, Shenzhen, Guangdong
Telephone: +86 13530802052
Email: caiyanling@secretech.com
Affiliation:  Shenzhen Second People's Hospital
Key inclusion & exclusion criteria
Inclusion criteria: 1. Plan a kidney biopsy to confirm the pathological type of kidney disease;
2. Sign the informed consent;
3. Aged over 18 years;
4. Have not undergone any invasive testing or treatment intervention.

Exclusion criteria: 1. Combined with infectious diseases such as hepatitis B, hepatitis C, HIV;
2. Combined with cardiovascular and cerebrovascular diseases, tumors and other diseases;
3. Patients with severe infectious diseases;
4. Pregnant and lactating patients;
5. Patients with severely impaired immune response (such as hypogammaglobulinemia, severe CD4 or CD8 cell count reduction);
6. Other conditions deemed inappropriate by other clinicians to participate in this study.


Age minimum: 18
Age maximum: 90
Gender: Both
Health Condition(s) or Problem(s) studied
membranous nephropathy
Intervention(s)
Gold Standard:kidney biopsy;Index test:types and amounts of proteins expressed in exosomes;
Primary Outcome(s)
exosomal protein CD26;;;;AUC of ROC;
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Hospital-level clinical research of Shenzhen Second People's Hospital
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 01/06/2021
Contact:
Xie Ni
Results
Results available:
Date Posted:
Date Completed:
URL:
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