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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: 16 August 2022
Main ID:  ChiCTR2100052808
Date of registration: 2021-11-05
Prospective Registration: Yes
Primary sponsor: Huadong Hospital of Fudan University
Public title: Mechanism of neutrophils activating cGAS-STING pathway through NETs to activate NLRP3 and promote macrophage pyrosis to promote behcet disease progression
Scientific title: Mechanism of neutrophils activating cGAS-STING pathway through NETs to activate NLRP3 and promote macrophage pyrosis to promote behcet disease progression
Date of first enrolment: 2022-01-01
Target sample size: Control group:20;Active period Behcet's disease(BD) group:20;Remission period BD group:20;
Recruitment status: Recruiting
URL:  http://www.chictr.org.cn/showproj.aspx?proj=136417
Study type:  Observational study
Study design:  Factorial  
Phase:  0
Countries of recruitment
China
Contacts
Name: Shen Yan   
Address:  221 Yan'an Road West, Jing'an District, Shanghai
Telephone: +86 13585569294
Email: shenyan1212@sina.com
Affiliation:  Huadong Hospital of Fudan University
Name: Shen Yan   
Address:  221 Yan'an Road West, Jing'an District, Shanghai
Telephone: +86 13585569294
Email: shenyan1212@sina.com
Affiliation:  Huadong Hospital of Fudan University
Key inclusion & exclusion criteria
Inclusion criteria: 1. Patients who fit the diagnosis of Behcet's disease (using the international classification criteria developed by the International Behcet Disease Study Group in 1990):
(1) Recurrent oral ulcer: doctors observed or patients complained of aphthal ulcer or scar, recurrent >= 3 times within a year;
(2) Recurrent genital ulcers: doctors have observed or patients have complained of aphthal ulcers, especially in men;
(3) Eye diseases: pre and/or post pigmenitis, cell infiltration in vitreous on slit lamp examination, or retinal vasculitis;
(4) Skin lesions: erythema nodosum lesions, pseudofolliculitis, purpuric papules, acne-like rash (without glucocorticoid);
(5) Positive acupuncture reaction: a 20 ml sterile needle was inserted diagonally into the skin, and the result was determined by the doctor 24-48 hours later;
Recurrent oral ulcers with 2 of the remaining 4 can be diagnosed as this disease;
2. Other symptoms that are closely related and helpful for diagnosis are arthralgia (arthritis).

Exclusion criteria: 1. Other diseases (infections, tumors, and other autoimmune diseases) cause symptoms similar to behcet's disease;
2. Patients with severe heart disease, cardiac insufficiency, liver dysfunction, renal insufficiency, respiratory failure, malignant tumor, gastrointestinal bleeding, etc.;
3. Mental patients;
4. Unable to take medicine on time for other reasons;
5. Pregnant and lactating women;
6. Patients who are participating in other clinical trials;
7. Clinical trial subjects who the researchers believe are not suitable for other reasons;
8. Major organ lesions: subcutaneous embolic phlebitis, deep venous embolism, arterial embolism and/or aneurysm, central neuropathy, digestive ulcer, epididymitis, and family history.


Age minimum: 18
Age maximum: 55
Gender: Both
Health Condition(s) or Problem(s) studied
Behcet's disease
Intervention(s)
Control group:No;Active period Behcet's disease(BD) group:No;Remission period BD group:No;
Primary Outcome(s)
Neutrophil extracellular traps (NETs);The expression of inflammatory factors;Infiltration of inflammatory cells;Macrophages-3;
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Huadong Hospital of Fudan University
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 31/10/2021
Contact:
Sha Yinghao
Results
Results available:
Date Posted:
Date Completed:
URL:
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