Long-term observation of children with primary immune thrombocytopenia
Clinical Characteristics, Prognosis and Prognostic Model of Pediatric Immune Thrombocytopenia: a Prospective, Multicenter, Observational Cohort Study
This study looks at how children with primary immune thrombocytopenia are treated and what their long-term health outcomes are in order to better understand the condition.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 6 Years to 17 Years |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Drugs / interventions | rituximab |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT06107582 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze the clinical characteristics, treatment methods, and prognosis of pediatric patients diagnosed with primary immune thrombocytopenia (ITP) in China. It will collect data from medical records and utilize questionnaires to assess patient exposure, with a focus on long-term follow-up to gather prognostic information. The study seeks to establish a comprehensive understanding of ITP in children, addressing the current gaps in large-scale prospective cohort studies.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric patients aged 6-17 years diagnosed with primary immune thrombocytopenia.
Not a fit: Patients with secondary thrombocytopenia or those expected to have a follow-up period of less than 3 months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment strategies and quality of life for children suffering from primary immune thrombocytopenia.
How similar studies have performed: While there have been smaller cohort studies on pediatric ITP, this study aims to provide a novel and comprehensive approach by establishing a large-scale longitudinal cohort.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 6-17 years old (including both ends), male and female; * Diagnosis of ITP. Exclusion Criteria: * Secondary thrombocytopenia caused by various reasons, such as connective tissue disorders, bone marrow hematopoietic failure disease, myelodysplastic syndrome, malignancy, drugs, inherited thrombocytopenia, common variable immune deficiency, lymphoma, etc.; * The expected follow-up period is less than 3 months.
Where this trial is running
Tianjin
- Chinese Academy of Medical Science and Blood Disease Hospital — Tianjin, China (Recruiting)
Study contacts
- Principal investigator: Lei Zhang, MD — Chinese Academy of Medical Science and Blood Disease Hospital
- Study coordinator: Ting Sun, MD
- Email: sunting@ihcams.ac.cn
- Phone: 02223909009
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.