Clinical trial NCT05230017: Chinese AntiphosPholipid Syndrome cohorT cOllaborative NEtworks
Official title: Chinese AntiphosPholipid Syndrome cohorT cOllaborative NEtworks
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anti Phospholipid Syndrome
Keywords: anti-phospholipid antibody
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Vascular thrombosis related to aPLs
timeFrame: 36 months
measure: Pregnancy morbidity related to aPLs
timeFrame: 36 months
Secondary outcomes:
measure: antiphospholipid antibody profile
timeFrame: 36 months
measure: Extra-criteria manifestations
timeFrame: 36 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Shunyi Hospital
state: Beijing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: The Second People's Hospital of Shenzhen
state: Guangdong
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Hohhot
country: China
facility: The Affilicated Hospital of Inner Mongolia Medical University
state: Inner Mongolia
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The Second Affiliated Hospical of Nanchang University
state: Jiangxi
city: Dalian
country: China
facility: The Second Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Medical University Genral Hospital
state: Tianjin
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Kunming
country: China
facility: First People's Hospital of Yunnan Province
state: Yunnan
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Peking Union Medical College Hospital
name: Jiuliang Zhao, M.D.
role: PRINCIPAL_INVESTIGATOR
References: