Main
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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:
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ChiCTR |
Last refreshed on:
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16 August 2022 |
Main ID: |
ChiCTR2100052808 |
Date of registration:
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2021-11-05 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Mechanism of neutrophils activating cGAS-STING pathway through NETs to activate NLRP3 and promote macrophage pyrosis to promote behcet disease progression
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Scientific title:
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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:
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2022-01-01 |
Target sample size:
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Control group:20;Active period Behcet's disease(BD) group:20;Remission period BD group:20; |
Recruitment status: |
Recruiting |
URL:
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http://www.chictr.org.cn/showproj.aspx?proj=136417 |
Study type:
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Observational study |
Study design:
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Factorial
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Phase:
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0
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Countries of recruitment
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China
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Contacts
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Name:
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Shen Yan
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Address:
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221 Yan'an Road West, Jing'an District, Shanghai
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Telephone:
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+86 13585569294 |
Email:
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shenyan1212@sina.com |
Affiliation:
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Huadong Hospital of Fudan University |
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Name:
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Shen Yan
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Address:
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221 Yan'an Road West, Jing'an District, Shanghai
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Telephone:
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+86 13585569294 |
Email:
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shenyan1212@sina.com |
Affiliation:
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Huadong Hospital of Fudan University |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Behcet's disease
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Intervention(s)
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Control group:No;Active period Behcet's disease(BD) group:No;Remission period BD group:No;
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Primary Outcome(s)
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Neutrophil extracellular traps (NETs);The expression of inflammatory factors;Infiltration of inflammatory cells;Macrophages-3;
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Source(s) of Monetary Support
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Huadong Hospital of Fudan University
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Ethics review
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Status: Approved
Approval date: 31/10/2021
Contact:
Sha Yinghao
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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