Chinese AntiphosPholipid Syndrome cohorT cOllaborative NEtworks

NCT ID: NCT05230017

Last Updated: 2024-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-01

Study Completion Date

2026-12-01

Brief Summary

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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

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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.

Conditions

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Anti Phospholipid Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jiuliang Zhao

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jiuliang Zhao, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Beijing Shunyi Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status RECRUITING

The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Site Status RECRUITING

The Second People's Hospital of Shenzhen

Shenzhen, Guangdong, China

Site Status RECRUITING

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Site Status RECRUITING

The Affilicated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

Site Status RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

The Second Affiliated Hospical of Nanchang University

Nanchang, Jiangxi, China

Site Status RECRUITING

The Second Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

Site Status RECRUITING

The First Hospital of China Medical University

Shenyang, Liaoning, China

Site Status RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Tianjin Medical University Genral Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Site Status RECRUITING

First People's Hospital of Yunnan Province

Kunming, Yunnan, China

Site Status RECRUITING

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jiuliang Zhao, M.D.

Role: CONTACT

0086-13810103105

Yangzhong Zhou, M.D.

Role: CONTACT

Facility Contacts

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Jiuliang Zhao, M.D.

Role: primary

0086-13810103105

Other Identifiers

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2021-12-28-2.0

Identifier Type: -

Identifier Source: org_study_id

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