ClinicalTrials.gov record NCT06417502
Observational Study of Pediatric Rheumatic and Immunologic Diseases in China: The CAPRID Registry
Observational Study of Pediatric Rheumatic and Immunologic Diseases in China: The CAPRID Registry
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
An observational, multi-center, prospective registry for Chinese children with rheumatic and immunologic diseases. It collects routine clinical data from hospital databases, a web-based registry, and a mobile app for long-term follow-up and patient-reported outcomes. No study interventions are assigned; treatment stays as decided by the treating clinicians.
What it is studying. The registry aims to gather real-world information about clinical features, diagnoses, complications, treatments, drug safety, adverse events, critical illness, and outcomes in Chinese pediatric patients with rheumatic and immunologic diseases, using standardized hospital databases and patient-reported data.
What the researchers hope to learn. To describe clinical phenotypes and diagnoses, monitor complications and outcomes, and collect real-world data on drug safety, therapeutic effectiveness, and adverse events in Chinese pediatric rheumatic and immunologic diseases; and to build standardized, multi-center data resources for research.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
An observational, multi-center, longitudinal registry study for Chinese pediatric patients with rheumatic and immunologic diseases.
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Age <= 18 years old
- Diagnosed with rheumatic and immunologic diseases (including diffuse connective tissue diseases, arthritis, vasculitis, inborn errors of immunity)
- Diagnosed and Treated in China
Exclusion criteria
- Disagreement of involving in this study by the patient or his/her family.
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
Pediatric rheumatic and immunologic diseases severely impact the health of children and adolescents. Chinese Alliance of Pediatric Rheumatic \& Immunologic Diseases (CAPRID) was founded in 2022 to form a national collaboration for high-quality data-driven multi-center pediatric rheumatology and immunology research in China. The CAPRID Registry is an observational, multi-center, longitudinal registry for Chinese pediatric patients with rheumatic and immunologic diseases to explore the clinical phenotypes, diagnoses, complications, real-world drug safety, therapeutic efficacy, adverse events, critical illness and outcomes of Chinese pediatric patients with rheumatic and immunologic diseases. Hospital-based databases are established and standardized with Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM) for routine data collection. A web-based registry website is established with standardized electronic case report forms to register patients from CAPRID centers. A mobile application is created to allow long-term follow up and patient-reported outcome collection. The data captured in this registry reflects a "real world" situation with no intervention done outside the routine clinical practice. Treatment plans are determined by the investigator.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants allow their routine clinical data and test results to be entered into a web-based registry and standardized hospital database, and use a mobile app for long-term follow-up and patient/parent-reported outcomes. Care and treatment remain determined by the treating clinician; the registry does not assign treatments. Expected activities include periodic physician assessments, patient or parent global assessments (patients older than 8 may self-report), questionnaires such as the CHAQ, and collection of routine clinical and laboratory data over time (target follow-up ~3 years; some registry outcomes tracked up to 10 years).
How the study is structured. A prospective, observational, multi-center registry. Data are collected from hospital records standardized to a common data model, entered into a web registry, and supplemented by a mobile app for follow-up. Participants continue routine clinical care; the registry tracks outcomes over time (target duration listed as 3 years; some outcome measures noted up to 10 years).
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
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Important dates
- Study start
- Apr 29, 2022
- Primary completion
- Nov 30, 2024 (estimated)
- Study completion
- Dec 31, 2031 (estimated)
- Target enrollment
- 20000 participants (estimated)
- Last updated on registry
- May 16, 2024
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Peking Union Medical College Hospital
- Principal investigator
- Hongmei Song, MD
Peking Union Medical College Hospital - Collaborators
- Children's Hospital of Chongqing Medical University
- Central South University
- Beijing Children's Hospital
- Shenzhen Children's Hospital
- Children's Hospital of Nanjing Medical University
- The University of Hong Kong
- Zhejiang University
- Peking University Third Hospital
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Sihao Gao 📞 (+86) 010-6915-5727 ✉ sihao.gao@gmail.com
Participating sites (9)
- Peking Union Medical College HospitalRecruiting
Beijing, Beijing Municipality, 100730 · China
- Hongmei Song, MD, PhD · +86-10-69156271 · songhm1021@126.com
- Sihao Gao · +86-10-69156271 · sihao.gao@gmail.com
- Hongmei Song, MD
- Beijing Children's Hospital, Capital Medical UniversityRecruiting
Beijing, Beijing Municipality · China
- Huawei Mao, MD, PhD
- Third Hospital of Peking UniversityRecruiting
Beijing, Beijing Municipality · China
- Zhiqiang Yan, PhD
- Chidren's Hospital of Chongqing Medical UniversityRecruiting
Chongqing, Chongqing Municipality · China
- Xuemei Tang, MD
- Shenzhen Children's HospitalRecruiting
Shenzhen, Guangdong · China
- Jun Yang, MD
- The University of Hong Kong Shenzhen Institute of Research and Innovation (HKU-SIRI)Recruiting
Shenzhen, Guangdong · China
- Wanling Yang, PhD
- The Second Xiangya Hospital of Central South UniversityRecruiting
Changsha, Hunan · China
- Xiaochuan Wu, MD
- Children's Hospital of Nanjing Medical UniversityRecruiting
Nanjing, Jiangsu · China
- Haiguo Yu, MD
- Children's Hospital of Zhejiang University School of MedicineRecruiting
Hangzhou, Zhejiang · China
- Meiping Lu, MD
Terms used on this page · explanations by MedicalUpdates.ai
- registry
- An organised collection of information about people with a particular condition, gathered over time for research. Joining a registry usually means sharing medical information, not receiving a treatment.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- adverse events
- Any unwanted medical problem that happens during a study, whether or not it was caused by the treatment. A 'serious' adverse event is one that meets specific criteria, such as causing death, being life-threatening, requiring or prolonging hospital admission, causing significant disability, or another medically important outcome.
- follow up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
- no intervention
- A study group that does not receive the intervention being tested and is observed for comparison.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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