Anti Phospholipid SyndromeCAPSTONENCT05230017
Chinese AntiphosPholipid Syndrome cohorT cOllaborative NEtworks
An observational study of Anti Phospholipid Syndrome, run by Peking Union Medical College Hospital at 18 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anti Phospholipid Syndrome
- How many people
- 2,000 participants
- Where
- 18 sitesChina
- Study dates
- 1 Oct 2022to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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:
Who cannot join
- Patients refuse to participate;
- Unable to be followed.
Trial locations and contacts
18 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Yangzhong Zhou, M.D. contact
18 sites in 1 country
China18 sites, 18 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Jiuliang Zhao, M.D., 0086-13810103105, Jiuliang.zhao@cstar.org.cn
- Recruiting
Beijing Shunyi Hospital
Beijing, Beijing Municipality, 101300
Xiaomin Liu, M.D.
- Recruiting
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116031
Xiaodan Kong, M.D.
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Shunping Lin, M.D.
- Recruiting
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510150
Jianyu Zhang, M.D.
- Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 311202
Jing Xue, M.D.
- Recruiting
The Affilicated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, 010110
Hongbin Li, M.D.
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Qiang Shu, M.D.
- Recruiting
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
Jian Xu, M.D.
- Recruiting
First People's Hospital of Yunnan Province
Kunming, Yunnan, 650032
Qin Li, M.D.
- Recruiting
The Second Affiliated Hospical of Nanchang University
Nanchang, Jiangxi, 330006
Xinwang Duan, M.D.
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Miujia Zhang, M.D.
- Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Cheng Zhao, M.D.
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Hui Shi, M.D.
- Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
Pingting Yang, M.D.
- Recruiting
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020
Dongzhou Liu, M.D.
- Recruiting
The Second People's Hospital of Shenzhen
Shenzhen, Guangdong, 518035
Meiying Wang, M.D.
- Recruiting
Tianjin Medical University Genral Hospital
Tianjin, Tianjin Municipality, 300052
Wei Wei, M.D.
About this study
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.
Read the 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.
- Conditions
- Anti Phospholipid Syndrome
- Keywords
- anti-phospholipid antibody
- Medical subject headings
- Antiphospholipid Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Vascular thrombosis related to aPLs
Venous thrombosis, arterial thrombosis, microscopic thrombosis
Measured: 36 months
Pregnancy morbidity related to aPLs
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.
Measured: 36 months
Secondary outcomes (2)
antiphospholipid antibody profile
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.
Measured: 36 months
Extra-criteria manifestations
Thrombocytopenia, haemolytic anemia, APS nephropathy, heart valve lesions, non-stroke CNS manifestations, skin changes (livedo reticularis, leg ulcers)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start1 Oct 2022
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anti Phospholipid SyndromeStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiuliang Zhao, Peking Union Medical College Hospital
- Investigators
- Jiuliang Zhao, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230017
- Sponsor's protocol ID
- 2021-12-28-2.0
- Acronym
- CAPSTONE
- Status last verified
- Jul 2024
- First submitted
- 27 Jan 2022
- Last updated
- 30 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chinese AntiphosPholipid Syndrome cohorT cOllaborative NEtworks
- ClinicalTrials.gov ID
- NCT05230017
- Acronym / sponsor ID
- CAPSTONE / 2021-12-28-2.0
- Conditions
- Anti Phospholipid Syndrome
- Keywords
- anti-phospholipid antibody
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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:
Key exclusion criteria (2 listed)
- Patients refuse to participate;
- Unable to be followed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Vascular thrombosis related to aPLs
Time frame: 36 months
Venous thrombosis, arterial thrombosis, microscopic thrombosis
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.
2 secondary outcomes
antiphospholipid antibody profile
Time frame: 36 months
Extra-criteria manifestations
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Anti Phospholipid Syndrome
Recruiting
Autoimmune Hemolytic Anemia and Its Clinical Implication on Antiphospholipid Syndrome
Anti Phospholipid Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yangzhong Zhou, M.D. contact
Jiuliang Zhao, M.D. principal investigator
Peking Union Medical College Hospital
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anti Phospholipid Syndrome, run by Peking Union Medical College Hospital at 18 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiuliang Zhao, M.D. (0086-13810103105, Jiuliang.zhao@cstar.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular thrombosis related to aPLs (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024; AzTrials last refreshed its copy on 1 Nov 2026.