Chinese AntiphosPholipid Syndrome cohorT cOllaborative NEtworks
CAPSTONE
1 other identifier
observational
2,000
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2022
Longer than P75 for all trials
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2022
CompletedFirst Posted
Study publicly available on registry
February 8, 2022
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
July 30, 2024
July 1, 2024
4.2 years
January 27, 2022
July 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Vascular thrombosis related to aPLs
Venous thrombosis, arterial thrombosis, microscopic thrombosis
36 months
Pregnancy morbidity related to aPLs
One or more unexplained deaths of a morphologically normal fetus at ≥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.
36 months
Secondary Outcomes (2)
antiphospholipid antibody profile
36 months
Extra-criteria manifestations
36 months
Eligibility Criteria
All patients with the presense of one or more of the following aPLs can be included, after obtaining the written informed consent. The aPLs include: 1)IgG and/or IgM anticardiolipin antibodies (aCL) in moderate or high titer (\>40 GPL or MPL units, respectively, or a titer \>99th percentile for the testing laboratory), measured by a standardized enzyme-linked immunosorbent assay (ELISA). 2) IgG and/or IgM anti-beta2-glycoprotein (GP) I \>40 GPL or MPL units, respectively, or a titer \>99th percentile for the testing laboratory, measured by a standardized ELISA according to recommended procedures. 3) Lupus anticoagulant (LA) activity detected according to published guidelines.
You may qualify if:
- 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:
You may not qualify if:
- Patients refuse to participate;
- Unable to be followed.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Beijing Shunyi Hospital
Beijing, Beijing Municipality, 101300, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510150, China
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020, China
The Second People's Hospital of Shenzhen
Shenzhen, Guangdong, 518035, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
The Affilicated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 010110, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
The Second Affiliated Hospical of Nanchang University
Nanchang, Jiangxi, 330006, China
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116031, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
Tianjin Medical University Genral Hospital
Tianjin, Tianjin Municipality, 300052, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032, China
First People's Hospital of Yunnan Province
Kunming, Yunnan, 650032, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 311202, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jiuliang Zhao, M.D.
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 27, 2022
First Posted
February 8, 2022
Study Start
October 1, 2022
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
July 30, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share