Chinese AntiphosPholipid Syndrome cohorT cOllaborative NEtworks

Last updated: July 29, 2024
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Antiphospholipid Syndrome

Thrombosis

Platelet Disorders

Treatment

N/A

Clinical Study ID

NCT05230017
2021-12-28-2.0
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The presence of one or more of the antiphospholipid antibodies (aPL) testedaccording to the 2006 Sapporo APS clasification criteria, on two or more occasionsat least 12 weeks apart:

Exclusion

Exclusion Criteria:

  • Patients refuse to participate;

  • Unable to be followed.

Study Design

Total Participants: 2000
Study Start date:
October 01, 2022
Estimated Completion Date:
December 01, 2026

Study 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.

Connect with a study center

  • Beijing Shunyi Hospital

    Beijing, Beijing 101300
    China

    Active - Recruiting

  • Peking Union Medical College Hospital

    Beijing, Beijing 100730
    China

    Active - Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian 350001
    China

    Active - Recruiting

  • The Third Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong 510150
    China

    Active - Recruiting

  • Shenzhen People's Hospital

    Shenzhen, Guangdong 518020
    China

    Active - Recruiting

  • The Second People's Hospital of Shenzhen

    Shenzhen, Guangdong 518035
    China

    Active - Recruiting

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi 530021
    China

    Active - Recruiting

  • The Affilicated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia 010110
    China

    Active - Recruiting

  • Jiangsu Province Hospital

    Nanjing, Jiangsu 210029
    China

    Active - Recruiting

  • The Second Affiliated Hospical of Nanchang University

    Nanchang, Jiangxi 330006
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning 116031
    China

    Active - Recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning 110001
    China

    Active - Recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong 250012
    China

    Active - Recruiting

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai 200025
    China

    Active - Recruiting

  • Tianjin Medical University Genral Hospital

    Tianjin, Tianjin 300052
    China

    Active - Recruiting

  • First Affiliated Hospital of Kunming Medical University

    Kunming, Yunnan 650032
    China

    Active - Recruiting

  • First People's Hospital of Yunnan Province

    Kunming, Yunnan 650032
    China

    Active - Recruiting

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang 311202
    China

    Active - Recruiting

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