Chinese AntiphosPholipid Syndrome cohorT cOllaborative NEtworks
- Conditions
- Anti Phospholipid Syndrome
- Registration Number
- NCT05230017
- Lead Sponsor
- Peking Union Medical College Hospital
- Brief Summary
Antiphospholipid syndrome (APS) is an autoimmune disorder characterized by thrombosis and pregnancy morbidity in patients with persistently positive antiphospholipid antibodies (aPLs). However, large-scale research on general population with persistent aPLs has been lacking. This project proposes to establish the first multicenter cohort of patients with persistently positive aPLs in China and conduct a comprehensive clinical phenotyping study. Based on traditional phenotypes of thrombotic and pregnancy events, the focus will be on extra-standard clinical phenotypes and prospective assessment of event risk and prognosis in aPL-positive population. A prospective analysis of extra-standard antibodies will also be conducted to recommend detection criteria for extra-standard antibody application in China and to assess their clinical significance.
- Detailed Description
Chinese AntiphosPholipid Syndrome cohorT cOllaborative NEtworks (CAPSTONE) is a national research network created to register patients with persistent aPLs. We aim at enrolling 2000 patients from a total of six centers, lead by the Peking Union Medical College Hospital (PUMCH). The aPLs assay will be validated in the central lab in PUMCH. All patients will be followed every six months, and up to three years. Thrombotic and pregnancy events related to aPLs will be recorded, as well as extra-criteria clinical phenotypes.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2000
- The presence of one or more of the antiphospholipid antibodies (aPL) tested according to the 2006 Sapporo APS clasification criteria, on two or more occasions at least 12 weeks apart:
- Patients refuse to participate;
- Unable to be followed.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Vascular thrombosis related to aPLs 36 months Venous thrombosis, arterial thrombosis, microscopic thrombosis
Pregnancy morbidity related to aPLs 36 months One or more unexplained deaths of a morphologically normal fetus at β₯10 weeks gestation, or one or more premature births of a morphologically normal neonate before 34 weeks gestation because of eclampsia, preeclampsia, or placental insufficiency, or three or more consecutive spontaneous pregnancy losses at \<10 weeks gestation, unexplained by chromosomal abnormalities or by maternal anatomic or hormonal causes.
- Secondary Outcome Measures
Name Time Method antiphospholipid antibody profile 36 months IgG and/or IgM anticardiolipin (ACL) antibodies, IgG and/or IgM anti-beta2-glycoprotein (GP), Lupus anticoagulant (LA) activity, IgA ACL/anti-Ξ²2-GP IοΌanti-annexin 5 antibody, anti-protein C, anti-protein S, anti-vimentin/cardiolipin complex, and anti-lysobisphosphatidic acid (LBPA) et al.
Extra-criteria manifestations 36 months Thrombocytopenia, haemolytic anemia, APS nephropathy, heart valve lesions, non-stroke CNS manifestations, skin changes (livedo reticularis, leg ulcers)
Trial Locations
- Locations (18)
Beijing Shunyi Hospital
π¨π³Beijing, Beijing, China
Peking Union Medical College Hospital
π¨π³Beijing, Beijing, China
The Third Affiliated Hospital of Guangzhou Medical University
π¨π³Guangzhou, Guangdong, China
Fujian Medical University Union Hospital
π¨π³Fuzhou, Fujian, China
The Affilicated Hospital of Inner Mongolia Medical University
π¨π³Hohhot, Inner Mongolia, China
Shenzhen People's Hospital
π¨π³Shenzhen, Guangdong, China
The Second People's Hospital of Shenzhen
π¨π³Shenzhen, Guangdong, China
Jiangsu Province Hospital
π¨π³Nanjing, Jiangsu, China
The First Affiliated Hospital of Guangxi Medical University
π¨π³Nanning, Guangxi, China
The Second Affiliated Hospital of Dalian Medical University
π¨π³Dalian, Liaoning, China
The First Hospital of China Medical University
π¨π³Shenyang, Liaoning, China
The Second Affiliated Hospical of Nanchang University
π¨π³Nanchang, Jiangxi, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
π¨π³Shanghai, Shanghai, China
Qilu Hospital of Shandong University
π¨π³Jinan, Shandong, China
First Affiliated Hospital of Kunming Medical University
π¨π³Kunming, Yunnan, China
Tianjin Medical University Genral Hospital
π¨π³Tianjin, Tianjin, China
First People's Hospital of Yunnan Province
π¨π³Kunming, Yunnan, China
The Second Affiliated Hospital Zhejiang University School of Medicine
π¨π³Hangzhou, Zhejiang, China