Review of medical records for children with Central Precocious Puberty in China
Patient Characteristics, Treatment Patterns, and Resource Usage in Children Diagnosed With Central Precocious Puberty (CPP) in China
This study looks at the medical records of around 1000 children in China with Central Precocious Puberty to see how they were treated and what resources were used over the past two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Takeda Industry-sponsored |
| Locations | 5 sites (Nanning, Guangxi and 4 other locations) |
| Trial ID | NCT05341128 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze medical records of approximately 1000 children diagnosed with Central Precocious Puberty (CPP) in China. It focuses on evaluating treatment patterns, participant characteristics, and resource usage over a period of 24 months or less. The study utilizes data from the Chinese CPP Big Data Platform database and will be conducted across multiple centers in China over approximately three years. No new treatments will be administered, as the study is retrospective and non-interventional.
Who should consider this trial
Good fit: Ideal candidates for this study are pediatric patients diagnosed with CPP who have been treated with GnRHa and have available medical records from the specified centers.
Not a fit: Patients who have not received GnRHa treatment or lack sufficient data for analysis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the treatment effectiveness and resource utilization for children with CPP, potentially guiding future treatment strategies.
How similar studies have performed: While this study is observational and retrospective, similar studies have successfully utilized medical record analysis to inform treatment practices in pediatric populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: • Participants diagnosed with CPP and treated with GnRHa from the centers participating in this study within the Chinese CPP Big Data Platform database since 2015 to 2024. CPP diagnosis is based on the clinical assessment and description by CPP specialized doctors. Exclusion Criteria: * Not received GnRHa as the treatment for CPP. * No available data for analysis.
Where this trial is running
Nanning, Guangxi and 4 other locations
- The Second Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China (Recruiting)
- Hainan Women and Children's Medical Center — Haikou, Hainan, China (Recruiting)
- Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology — Wuhan, Hubei, China (Recruiting)
- Shandong Provincial Hospital Affiliated to Shandong First Medical University — Jinan, Shandong, China (Recruiting)
- Tianjin Medical University General Hospital — Tianjin, Tianjin, China (Recruiting)
Study contacts
- Study coordinator: Takeda Contact
- Email: medinfoUS@takeda.com
- Phone: +1-877-825-3327
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.