Chinese AntiphosPholipid Syndrome cohorT cOllaborative NEtworks (CAPSTONE)

July 29, 2024 updated by: Jiuliang Zhao, Peking Union Medical College Hospital

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.

Study Overview

Status

Recruiting

Conditions

Anti Phospholipid Syndrome

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.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Yangzhong Zhou, M.D.
Email: zhouyangzhong@pumch.cn

Study Contact Backup

Name: Jiuliang Zhao, M.D.
Phone Number: 0086-13810103105
Email: Jiuliang.zhao@cstar.org.cn

Study Locations

China
- Beijing
  - Beijing, Beijing, China, 100730
    - Recruiting
    - Peking Union Medical College Hospital
    - Contact:
      
      Jiuliang Zhao, M.D.
      
      Phone Number: 0086-13810103105
      
      Email: Jiuliang.zhao@cstar.org.cn
  - Beijing, Beijing, China, 101300
    - Recruiting
    - Beijing Shunyi Hospital
    - Principal Investigator:
      
      Xiaomin Liu, M.D.
- Fujian
  - Fuzhou, Fujian, China, 350001
    - Recruiting
    - Fujian Medical University Union Hospital
    - Principal Investigator:
      
      Shunping Lin, M.D.
- Guangdong
  - Guangzhou, Guangdong, China, 510150
    - Recruiting
    - The Third Affiliated Hospital of Guangzhou Medical University
    - Principal Investigator:
      
      Jianyu Zhang, M.D.
  - Shenzhen, Guangdong, China, 518035
    - Recruiting
    - The Second People's Hospital of Shenzhen
    - Principal Investigator:
      
      Meiying Wang, M.D.
  - Shenzhen, Guangdong, China, 518020
    - Recruiting
    - Shenzhen People's Hospital
    - Principal Investigator:
      
      Dongzhou LIU, M.D.
- Guangxi
  - Nanning, Guangxi, China, 530021
    - Recruiting
    - The First Affiliated Hospital of Guangxi Medical University
    - Principal Investigator:
      
      Cheng Zhao, M.D.
- Inner Mongolia
  - Hohhot, Inner Mongolia, China, 010110
    - Recruiting
    - The Affilicated Hospital of Inner Mongolia Medical University
    - Principal Investigator:
      
      Hongbin LI, M.D.
- Jiangsu
  - Nanjing, Jiangsu, China, 210029
    - Recruiting
    - Jiangsu Province Hospital
    - Principal Investigator:
      
      Miujia Zhang, M.D.
- Jiangxi
  - Nanchang, Jiangxi, China, 330006
    - Recruiting
    - The Second Affiliated Hospical of Nanchang University
    - Principal Investigator:
      
      Xinwang DUAN, M.D.
- Liaoning
  - Dalian, Liaoning, China, 116031
    - Recruiting
    - The Second Affiliated Hospital of Dalian Medical University
    - Principal Investigator:
      
      Xiaodan Kong, M.D.
  - Shenyang, Liaoning, China, 110001
    - Recruiting
    - The First Hospital of China Medical University
    - Principal Investigator:
      
      Pingting Yang, M.D.
- Shandong
  - Jinan, Shandong, China, 250012
    - Recruiting
    - Qilu Hospital of Shandong University
    - Principal Investigator:
      
      Qiang Shu, M.D.
- Shanghai
  - Shanghai, Shanghai, China, 200025
    - Recruiting
    - Ruijin Hospital, Shanghai Jiaotong University School of Medicine
    - Principal Investigator:
      
      Hui Shi, M.D.
- Tianjin
  - Tianjin, Tianjin, China, 300052
    - Recruiting
    - Tianjin Medical University Genral Hospital
    - Principal Investigator:
      
      Wei Wei, M.D.
- Yunnan
  - Kunming, Yunnan, China, 650032
    - Recruiting
    - First Affiliated Hospital of Kunming Medical University
    - Principal Investigator:
      
      Jian Xu, M.D.
  - Kunming, Yunnan, China, 650032
    - Recruiting
    - First People's Hospital of Yunnan Province
    - Principal Investigator:
      
      Qin Li, M.D.
- Zhejiang
  - Hangzhou, Zhejiang, China, 311202
    - Recruiting
    - The Second Affiliated Hospital Zhejiang University School of Medicine
    - Principal Investigator:
      
      Jing XUE, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

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:

Exclusion Criteria:

Patients refuse to participate;
Unable to be followed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vascular thrombosis related to aPLs Time Frame: 36 months	Venous thrombosis, arterial thrombosis, microscopic thrombosis	36 months
Pregnancy morbidity related to aPLs Time Frame: 36 months	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
antiphospholipid antibody profile Time Frame: 36 months	IgG and/or IgM anticardiolipin (ACL) antibodies, IgG and/or IgM anti-beta2-glycoprotein (GP), Lupus anticoagulant (LA) activity, IgA ACL/anti-β2-GP I，anti-annexin 5 antibody, anti-protein C, anti-protein S, anti-vimentin/cardiolipin complex, and anti-lysobisphosphatidic acid (LBPA) et al.	36 months
Extra-criteria manifestations Time Frame: 36 months	Thrombocytopenia, haemolytic anemia, APS nephropathy, heart valve lesions, non-stroke CNS manifestations, skin changes (livedo reticularis, leg ulcers)	36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

Principal Investigator: Jiuliang Zhao, M.D., Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

January 27, 2022

First Submitted That Met QC Criteria