A Study of Medical Records From Children With Central Precocious Puberty (CPP) in China

Study Overview
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Brief Summary
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The main purpose is to describe how many children were treated during 24 months or less because of CPP and how treatment worked for them. There are no participants in this trial, the study only involves reviewing participants medical past and current records and collecting information.

Detailed Description
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This is an observational, non-interventional, retrospective study to evaluate the participants characteristics, current treatment patterns and resource usage in Chinese pediatric participants diagnosed with CPP. This study will enroll approximately 400 participants. The data available in an existing data source the Chinese CPP Big Data Platform database will be analyzed. All the participants will be assigned to a single observational cohort: • Pediatric Participants With CPP This multi-center trial will be conducted in China. The overall duration of the study will be approximately 18 months.

Official Title
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Patient Characteristics, Treatment Patterns, and Resource Usage in Children Diagnosed With Central Precocious Puberty (CPP) in China

Conditions
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Central Precocious Puberty

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The CPP database already includes participants with CPP diagnosed according to the 2015 version of The Consensus on the Diagnosis and Treatment of Central Precocious Puberty. All patients in the database are eligible CPP participants. Exclusion Criteria: Participants with CPP due to identified etiology such as tumors, exogenous factors, congenital adrenal hyperplasia (CAH), and Mccune-Albright syndrome, hepatopathy, nephropathy, congenital heart disease, and hereditary metabolic diseases will be excluded.

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pediatric Participants With CPP<br>Pediatric participants who have been diagnosed with CPP per criteria set in the 2015 version of The Consensus on the Diagnosis and Treatment of Central Precocious Puberty and have received treatment or medical services in China between 07 August 2015 and 31 December 2024 will be assessed retrospectively using the Chinese CPP Big Data Platform database. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) |  | From 07 August 2015 to 31 December 2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Change From Baseline in Decreased Ratio of Bone Age Over Chronological Age |  | Baseline up to 31 December 2022 | 
| Percentage of Participants With Change From Baseline in Decreased Ratio of Predicted Adult Height |  | Baseline up to 31 December 2022 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Central Precocious Puberty