National cohort for patients with antiphospholipid syndrome in China
Chinese AntiphosPholipid Syndrome cohorT cOllaborative NEtworks
This study is trying to learn more about antiphospholipid syndrome by following 2,000 patients in China with positive antiphospholipid antibodies to see how it affects their health over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 18 sites (Beijing, Beijing Municipality and 17 other locations) |
| Trial ID | NCT05230017 on ClinicalTrials.gov |
What this trial studies
This project aims to establish the first multicenter cohort of patients in China with persistently positive antiphospholipid antibodies (aPLs) to better understand antiphospholipid syndrome (APS). The study will enroll 2000 patients from six centers, led by Peking Union Medical College Hospital, and will focus on comprehensive clinical phenotyping, including thrombotic and pregnancy events. Patients will be followed every six months for up to three years to assess event risk and prognosis, as well as the clinical significance of extra-standard antibodies. The findings may help refine detection criteria for aPLs in the Chinese population.
Who should consider this trial
Good fit: Ideal candidates are individuals with one or more antiphospholipid antibodies present on two or more occasions at least 12 weeks apart.
Not a fit: Patients who refuse to participate or are unable to be followed will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and management of antiphospholipid syndrome in patients with persistent aPLs.
How similar studies have performed: While there have been studies on antiphospholipid syndrome, this cohort approach in China is novel and aims to fill a significant gap in large-scale research.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing Municipality and 17 other locations
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Beijing Shunyi Hospital — Beijing, Beijing Municipality, China (Recruiting)
- Fujian Medical University Union Hospital — Fuzhou, Fujian, China (Recruiting)
- The Third Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)
- Shenzhen People's Hospital — Shenzhen, Guangdong, China (Recruiting)
- The Second People's Hospital of Shenzhen — Shenzhen, Guangdong, China (Recruiting)
- The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China (Recruiting)
- The Affilicated Hospital of Inner Mongolia Medical University — Hohhot, Inner Mongolia, China (Recruiting)
- Jiangsu Province Hospital — Nanjing, Jiangsu, China (Recruiting)
- The Second Affiliated Hospical of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
- The Second Affiliated Hospital of Dalian Medical University — Dalian, Liaoning, China (Recruiting)
- The First Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
- Qilu Hospital of Shandong University — Jinan, Shandong, China (Recruiting)
- Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)
- Tianjin Medical University Genral Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
- First Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China (Recruiting)
- First People's Hospital of Yunnan Province — Kunming, Yunnan, China (Recruiting)
- The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Jiuliang Zhao, M.D. — Peking Union Medical College Hospital
- Study coordinator: Jiuliang Zhao, M.D.
- Email: Jiuliang.zhao@cstar.org.cn
- Phone: 0086-13810103105
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.